6 Research on Humans

Under federal law, institutions like Plymouth State University must create a group called the Institutional Review Board (IRB) to review and approve (or not) research that involves humans in order to ensure that no one is harmed by the research activities. Some of the projects that you might want to undertake in Tackling a Wicked Problem may need to be reviewed by the IRB. This chapter explains the circumstances for which you will need IRB approval for your project as well as the process for applying for IRB approval should you need to do so.

Do I need IRB approval for my class project?

Generally speaking, if the data are staying in the classroom (assignment being done for grading only) and data/results won’t be shared outside the classroom, IRB approval is not needed. If data may be used for an honors thesis, or presented at the Showcase of Student Research and Engagement (for example), then the project will need IRB approval as dissemination at those public events as research data is considered to be contributing to generalizable knowledge.

Individuals who wish to gather data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice AND intend to use the data as research data for the purpose of publishing or sharing with a research community or the public at large, must obtain IRB approval PRIOR to conducting the activity.

The PSU IRB recognizes that human subjects may be harmed by unethical or careless activities resulting from evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice. As a board that values the protection of human subjects and the conduct of ethical behavior, the board strongly disapproves of such unethical behavior. However, the IRB recognizes the limits of its mandate and authority. The actions of individuals conducting classroom activities are also governed by the ethical standards of their discipline (e.g., American Psychological Association or American Anthropological Association).
IRB approval is required for activities that 1) involve human subjects and 2) meet the definition of “research.” According to the federal guidelines, “research” is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

A systematic investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:

• Collection of quantitative or qualitative data
• Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
• Collection of data using experimental designs such as clinical trials
• Observation of individual or group behavior

A contribution to generalizable knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include one or more of the following:

• Presentation of the data at meetings, conferences, seminars, poster presentations, etc. – including the poster symposium at the end of the semester
• The knowledge contributes to an already established body of knowledge
• Other investigators, scholars, and practitioners may benefit from this knowledge
• Publications including journals, papers, dissertations, and master’s theses

If the project does not meet the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, then the project does not require IRB review and an IRB application is not required.
Examples of studies that ARE considered research with human subjects:

1. Studies that utilize test subjects for new devices, products, drugs, or materials.
2. Studies that collect data through intervention or interaction with individuals, if the information is about the individuals (including their opinions/views/thoughts). Examples of this type of research include behavioral interventions, surveys, studies that involve deception, research involving risky behaviors or attitudes, focus groups, and open-ended interviews with minors that contribute to generalizable knowledge.
3. Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
4. Studies that use human bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if the researcher did not collect these materials for the study. However, such research may not be considered human subjects research if the materials/data are coded and the investigator does not have access to the coding systems. Guidance on research involving coded private information or biological specimens is available here; https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/index.html.
5. Studies that produce generalizable knowledge about categories or classes of subjects from identifiable private information.
6. Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications to their living or working space or test chamber.

Examples of studies that are NOT considered research with human subjects:

1. Data collection for internal departmental or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
2. Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Example: a survey of employers that asks whether the employers offer certain employee benefits programs, without asking for the opinions or thoughts of the individuals who respond to the survey.
3. Activities involving human subjects within the context of research methods courses generally do not require IRB review, unless the results will be used for research purposes (e.g., presented at PSU undergraduate or graduate research conferences or used in a thesis or dissertation).
4. Program evaluation/quality improvement/quality assurance projects are generally not considered research if these activities are designed specifically to assess or improve performance within a department, hospital or classroom setting. The intention of the project is not to generate conclusions that can be applied universally, outside of the immediate environment where the project occurs. To determine whether a proposed quality improvement activity also qualifies as research (thus requiring IRB review), consult the Office of Human Research Protections (OHRP) guidance on quality improvement activities here: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/

How do I apply for IRB approval?

If you believe your project needs IRB approval, below are the steps to follow next:

1. Complete the mandatory CITI Research training which can be found here: https://campus.plymouth.edu/research-administration/training-2/compliance-training-citi/.
2. Email psu-irb@plymouth.edu to ensure that your project needs IRB approval. Your subject line should be: Tackling a Wicked Problem. Provide a brief summary of your project including the participants you will be working with and the basic methodology.
3. If the IRB determines that your project needs IRB approval, complete the IRB application checklist, IRB application, and informed consent documents which can all be found here: https://campus.plymouth.edu/institutional-review-board/how-to-apply/
4. Submit your documents and CITI Training certificate to psu-irb@plymouth.edu.

Once you submit your application to the IRB, you will get a response in 1 to 4 weeks. You should include this time in your project planning.