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, regardless 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, all research involving human subjects must be reviewed or deemed exempt from review by the HSRB.
The Office of Human Research Protections of the US Department of Health and Human Services provides a variety of resources for investigators. Among them are research activity decision trees, relevant regulations and documents that guide compliance with those regulations.
Metropolitan State University is a member of the Collaborative Institutional Training Initiative (CITI). Researchers are strongly encouraged to complete CITI training prior to submitting an application to the HSRB.
Research conducted by students
Independent student research projects, including senior or capstone theses, undergraduate research projects, master's and doctoral projects and similar, must be submitted to the HSRB. However, a faculty member is ultimately responsible for the protection of human subjects and must be designated as principal investigator (PI)/responsible project investigator (RPI), even if it is the student who is undertaking the research activities.
As assurance that the University's guidelines will be followed, the faculty member is required to sign, as PI/RPI the student's application to the HSRB. After approval, the PI/RPI should take an active role in ensuring that projects are conducted in accordance with the HSRB's requirements. During the entire project, it is incumbent upon faculty members to instruct students on the ethical conduct of research and help them prepare applications for HSRB approval. In particular, the faculty supervisor is to assure that students:
- understand the elements of informed consent,
- develop a readable and understandable consent form,
- plan appropriate strategies for recruiting and informing subjects,
- establish and maintain strict guidelines for protecting confidentiality, and
- allow sufficient time for the HSRB to complete its review of the project, including the review of required modifications.
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 and draw conclusions from the data, 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 participant)
- student projects will not involve any personal, sensitive, or incriminating topics or questions that could place participants 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.
Highly ambitious projects and projects that involve sensitive topics and/or 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 participants, 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. Participants should be told that the study is a pilot.
Research involving secondary use of data/broad consent
Projects that use previously gathered human subjects data, and that meet the definition of human subjects research, require HSRB review. However, under certain conditions, researchers may seek Broad Consent (consent for future research for which full specifics are not known at the time of the original application) that allows for subsequent use of participant data or biospecimens. In this case, the following conditions apply:
- The following basic elements: risks, benefits, confidentiality, statement that research participation is voluntary, statement regarding commercial profit (when appropriate) and statement regarding whole genome sequencing (when appropriate)
- The following statement: "Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent."
- A general description of the types of research that might be conducted in future analysis. The HSRB must assess whether the description of the research included in the broad consent form is adequate to permit a reasonable person to provide consent for the currently proposed secondary research study.
- A description of the information or biospecimens that might be used in future research, whether sharing might occur, and the types of institutions or researchers that might conduct research. -A description of the length of time that the information or biospecimens may be stored, maintained, and used.
- A statement whether subjects will or will not be informed of the details of any subsequent research.
- A statement that research results either will or will not be disclosed to subjects.
- Contact information
Research conducted at or in collaboration with another institution or off-campus site
Regardless of the research site, any human subjects 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. However, federal regulations do provide for single Institutional Review Board (sIRB) review for multi-site studies under certain circumstances. See the federal guidelines for Granting Exceptions or Single IRB Review for Multi-Site Research. Researchers engaged in projects for which Metropolitan State is not the sIRB must file the approving institution's notice of approval, as well as the specifics of the researcher's involvement in the project, with the HSRB.
If no human subjects 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 researcher is a consultant, the researcher is deemed to be conducting research and HSRB approval is required, unless all three of the following are true: 1. The researcher consults or is hired on his or her own time, 2. the researcher holds no rights in the work, and 3. neither the researcher nor Metropolitan State University retains any data.