Student Class Assignments vs. Research

Policy Number: 09
Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Effective Date: 5/23/24

Policy

All College of St. Scholastica student research activities that involve human subjects must be supervised by CSS faculty. Classroom research assignments do not require IRB review beyond faculty supervision if the goal of the classroom research assignment is educational and not intended for generalizable knowledge.

Purpose

The purpose of this policy is to help clarify when student research falls under the purview of the CSS IRB and when it most probably does not. This policy applies only to activities that involve class assignments. The College of St. Scholastica follows federal regulation and requires that all research involving human subjects with the intent to contribute to generalizable knowledge conducted by faculty, staff, or students affiliated with CSS be reviewed and approved by the CSS IRB. Investigations designed to develop or contribute to generalizable knowledge are those that seek to draw general conclusions, inform policy, create theories, or generalize findings that may be disseminated beyond CSS. While such research is often disseminated through scholarly publication or presentation of the data, research results do not need to be published or presented to qualify as generalizable knowledge. The intent to contribute to generalizable knowledge makes an experiment or data collection research, regardless of publication or presentation.

Definitions

Research

The Regulatory definition of research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (45 CFR 46.102)

Systematic Investigation

To be considered a systematic investigation the research project must meet all the following:

• Attempt to answer research questions.
• Is methodologically driven, that is, it collects data or information in an organized and consistent way.

• The data or information are analyzed in some way, be it quantitative or qualitative data.
• Conclusions are drawn from the results.

Generalizable Knowledge

To be considered generalizable knowledge one or more of the following would be included:

• The knowledge contributes to a theoretical framework of an established body of knowledge.
• The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study.
• Publication, presentation or other distribution of the results is intended to inform the field of study.
• The results are expected to be generalized to a larger population beyond the site of data collection or population studied.
• The results are intended to be replicated in other settings.

Minimal Risk

The Regulatory definition of minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests (45 CFR 46.102(i). (See also, CSS IRB SOP #13 IRB Determination of Minimal Risk.)

Some examples of minimal risk may include the following:

• Research conducted in educational settings, using normal educational practices that are unlikely to adversely impact either students’ opportunity to learn required content or the assessment of instructors who provide the instruction. (See, CSS IRB SOP #10 Exempt Determination Review Process and Checklist.)
• Research using educational tests, survey procedures, interview procedures or observation of public behavior if the data is non-sensitive and anonymous. (See, CSS IRB SOP #26 Survey Research and Internet Research.)
• Research involving benign behavioral interventions (brief, painless, unlikely to have significant lasting adverse effects, and the subjects are unlikely to find the intervention offensive or embarrassing) with consenting adult subjects and the data is anonymous and non-sensitive.
• Secondary research (research using existing data, documents, records, pathological specimens, or diagnostic specimens) if the data is publicly available and anonymous.

Vulnerable Populations

The Code of Federal Regulations defines vulnerable populations as pregnant women, human fetuses and neonates (45 CFR 46 Subpart B) (CSS IRB SOP #35 Research Involving Pregnant Women and Checklist); prisoners (Subpart C) (CSS IRB SOP #34 Research Involving Prisoners) and children (Subpart D) (CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist).

The National Institute of Health cautions that careful consideration should be used when including individuals with diminished decision-making capacity. If the study’s inclusion criteria and recruitment plan include individuals with disorders commonly associated with decision-making impairments, some form of screening may be useful. After assessing study risks, anticipated benefits, complexity, availability

of LARs, and patient characteristics, the IRB’s next step would be to determine which additional safeguards would be appropriate. Examples of additional protections include having a third party observe the consent process, having a subject advocate assist the subject, engaging consultant reviewers or requiring additional monitoring of the research.

The Presidential Commission for the Study of Bioethical Issues adds military personnel to the list of vulnerable populations. They might feel that participation could contribute to promotions, easier assignments, or special privileges; or that refusal to participate could result in demotions or other punitive measures. Moreover, the success of military operations depends in part on giving up some individual autonomy for the good of the whole; for this reason, soldiers might be coerced to participate in research if it is considered to be for the greater good.

In addition, vulnerable populations may include subjects that are unable to protect their own interests. This includes situations where they are legally prohibited, have impaired decision-making capacity or are economically-disadvantaged. These limitations prevent the individuals from providing effective informed consent or make them subject to possible coercion or undue influence.

Exempt Research

Exempt research (See, CSS IRB SOP #10 Exempt Determination Review Process and Checklist) is based on risk to the human subjects. Research that is low risk undergoes an Exempt review at the CSS IRB. It must be certified as Exempt before any data is collected. Research involving children and other vulnerable populations is not eligible for Exempt review. An example of Exempt research is an anonymous survey, either online or on paper, with no identifying data.

Expedited Research

If the research does not qualify as Exempt, it will require “Expedited” or “Full-board” review. If the research is considered to have “minimal risk” to the human subject, it may qualify as Expedited (See, CSS IRB SOP #11 Expedited Review Procedure and Checklist). Typically, the most substantial risk in behavioral and social science research at CSS involves loss of confidentiality. Research involving children and other vulnerable populations may be either Expedited or may require Full-board review.

Sensitive Topics

Research involving topics that may cause greater than minimal distress or confidential information that could place a participant at risk if disclosed are considered sensitive topics. Any interview, survey, (CSS IRB SOP #26 Survey Research and Internet Research) or questionnaire that proposes to investigate opinions, behaviors, and/or experiences regarding – but not limited to – any of the following sensitive topics require IRB review and approval:

• Sexual orientations, sexual harassment, sexual assault, sexual molestation or abuse, incest, practices of contraception, abortion, and/or pregnancy;
• Substance use and/or abuse including, but not limited to, alcohol, marijuana, steroids, amphetamines, narcotics, any prescription medication legally or illegally obtained;
• Questions regarding mental health (e.g. suicide, depression, obsessive-compulsive disorders, drug use, underage drinking, gambling, and/or eating disorders);
• Traumatic experiences (e.g. being a victim of violence, child abuse, senior abuse, war or conflict experiences).

What Qualifies as a Classroom Research Assignment ?

All the following must be true for human subjects research conducted in a classroom setting to be considered outside the purview of the IRB (no IRB approval needed):

• The research is a normal part of the student’s coursework;
• It is supervised by a faculty member;
• The primary purpose is the development of student skills;
• It does not involve more than minimal risk;
• It does not involve any persons who could be considered protected or vulnerable;
• It does not involve personally private, incriminating, or sensitive topics;
• It is not pursued in order to publish the results or share at professional and academic conferences and gatherings;
• There is no intent to produce generalizable knowledge or to disseminate the findings beyond presentation to instructors or peers in a CSS classroom setting or local CSS campus venue, or CSS departmental or interdepartmental seminars.

Revision to the Common Rule definition of “Research” removes the following activities from IRB review:

1. Certain scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
2. Public health surveillance activities ordered, required, or authorized by a public health authority necessary for assessing or monitoring public health outbreaks;
3. Collections/analyses by law or court order solely for criminal justice or criminal investigative purposes for criminal justice or criminal investigative purposes;
4. Federal agency-authorized activities in support of specified missions of intelligence, homeland security, defense, or other national security missions.

Researchers planning to undertake such activities are encouraged to discuss potential projects with the CSS IRB to be certain the project’s scope falls within permissible parameters.

CSS IRB approval is required If the research will be published ( including a thesis or dissertation) or given as a presentation outside of a CSS venue. Research projects conducted by students, such as theses, dissertations, honors projects, capstone projects, and independent study projects, that collect data outside of the classroom through interactions with living people or access to private information fall under the jurisdiction of the IRB. These research projects must be approved by the student’s Faculty Advisor before coming to the IRB.

References

45 CFR 46.102

National Institute of Health, November 2009, Research Involving Individuals with Questionable Capacity to Consent: Points to Consider - https://grants.nih.gov/grants/policy/questionablecapacity.htm)

University of Pittsburgh - https://www.irb.pitt.edu/content/research-involving-students-research-participants University of Oshkosh -

https://grants.uwosh.edu/wp-content/uploads/2017/01/IRB-SOP-7-Student-Class-Assignments-Updated-12-15-16-1.pdf

University of Tennessee, Knoxville - https://irb.utk.edu/faq/

University of St. Thomas - https://www.stthomas.edu/media/irb/doc/SOP_ClassroomandStudentResearch_07.13.18.pdf University of Alabama at Birmingham

https://irb.research.chop.edu/sites/default/files/documents/irbsop501_vulnerablesubjects_09_25_2018.pdf

The Presidential Commission for the Study of Bioethical Issues https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/3%20Vulnerable%20Populations%20Background%209.30.16.pdf

Children’s Hospital of Philadelphia - https://irb.research.chop.edu/sites/default/files/documents/irbsop501_vulnerablesubjects_09_25_2018.pdf