SOP #08 CSS Students as Research Subjects and School Age Children as Research Subjects - Coercion and Undue Influence

CSS Students as Research Subjects and School Age Children as Research Subjects - Coercion and Undue Influence

Policy Number: 08
Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Effective Date: 5/23/24

1. Policy

It is the policy of this institution that when students are used as research participants, the researchers should carefully review and understand the concepts of coercion and undue influence.

2. Purpose

The purpose of this policy is to describe the information required within IRB application materials, the process and procedures of review when the research project involves The College of St. Scholastica (CSS) students as human subjects as well as CSS students using school age children as human subjects in their research proposal.

3. Definitions

Student Children

The regulations define children as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45CFR46.402(a)).

Minnesota Statute Section 645.451 defines a minor as an individual under the age of 18. Minnesota defines an adult as an individual 18 years of age or older.

It is reasonable to grant younger college students a waiver of parental permission for minimal risk research, as it is a matter of justice to be considered equal with their classmates. Researchers are referred to SOPs 15 and 16 for information about waivers.

Such a waiver is difficult to justify in high school students (e.g. Seniors) and parental permission should be obtained. When minors are involved, even for educational research, Subpart D (Children) must be addressed by researchers and the IRB (See, CSS IRB SOP #33 Research Involving Children and Investigator Reviewer Checklist). When research involves both high school minors and non-minors () requirements for both populations must be addressed. Parental permission must be included for students under the age of eighteen (18). Best practice is to refer this issue to the CSS IRB. The CSS IRB may request the student’s high school administration’s policy on this issue.

Coercion or Undue Influence

The regulations require that the investigator seek consent only under circumstances that minimize the possibility of coercion or undue influence (45 CFR 46.116) (See also, CSS IRB SOP #16 Informed Consent w/ Checklist and Templates). The Office for Human Research Protections (OHRP) recommends that institutions have policies in place that clarify for students and faculty that any participation of students in research must be voluntary. Reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit for the possibility of undue influence to be minimized. However, if participation in research is a course requirement, students must be informed of non-research alternatives involving comparable time and effort to fulfill those requirements for the possibility of undue influence to be minimized. Moreover, students must not be penalized for refusing to participate in research (45 CFR 46.116(a)(8)).

Research Conducted in Classrooms

Research conducted in classrooms, which is a common way research on students is done, can take several forms:

  • A teacher or professor may be conducting research on their students for the purpose of producing generalizable knowledge. This can be a challenging situation for the CSS IRB because of the power differential between professor and student and the possibility of undue influence. When the CSS IRB considers this a problem, the IRB may require another professor to obtain consent and potentially conduct the study (e.g. a survey) (See, CSS IRB SOP #26 Survey Research and Internet Research). While a student’s professor may have authority over them in a classroom, the student must still be afforded their rights to say no and not to suffer any untoward effects of a decision to say no or withdraw from research.
    • PIs conducting pedagogical research in their classes must distinguish between additional activities related to research and regular classroom activities that would take place regardless of the research.
  • A teacher or professor may conduct, or may have the students conduct, research within the classroom to teach the students about research methodology or research about the class. The intent is educational and not to produce generalizable knowledge. This type of research is usually minimal risk and since it does not meet the definition of human subjects and is not reviewed by the IRB. Many professors have the students act as an IRB for research to teach them about human research protection. It is a best practice to have policies and procedures about classroom research to clarify when IRBs are not involved and when IRB review is required. (See, CSS IRB SOP #09 Student Class Assignment v Research.)
  • A teacher or professor may have the students conduct research externally from the classroom on other students or subjects. Large census populations of students, staff, faculty or alumni, should not be used as convenience samples without IRB approval. If the study meets the definitions of research and human subjects, the IRB must be involved.

4. Recruitment

Young students, particularly, may volunteer to participate in research in an effort to please a teacher (e.g., as when credit is given for participation in class) or because they fear that failure to participate will negatively affect their relationship with the teacher-investigator or faculty in general (i.e., by seeming uncooperative or unaware of scholarly research). Students’ cultural or religious backgrounds (e.g., requiring deference to authority figures) may also influence their

choices. A student’s decision about research participation may not affect (favorably or unfavorably) grades, potential letters of recommendation, or other opportunities or decisions made by teacher-investigators.

Except in unusual circumstances, investigators should not enroll students from their own classes when the research involves greater than minimal risk without the prospect of direct benefit.

Such studies should proceed only where the IRB determines that adequate provisions have been made to minimize the possibility of coercion, and the research is significant and cannot be conducted without the enrollment of these students. This caution about teachers recruiting their students may be extended to family members and relatives.

Many universities and colleges have “student research pools,” where professors or graduate students submit research studies into a “pool” of studies and utilize the student population “pool” as subjects. Such studies are used to produce generalizable knowledge, including theses and dissertations, although many professors also use such research to educate students about research. Students who sign up for such pools have not legally consented to participate in a research study since they have not been provided with sufficient information concerning the exact study in which they would participate. This research must be reviewed by the IRB. The IRB must consider the following:

  • That the research is voluntary.
  • The student can say no with no unfortunate consequences.
  • If the student signs up for a study and does not show up, this is considered withdrawal and within the rights of the student and thus there should be no consequences (OHRP: Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments [January 8, 2010]).

Some professors may offer a non-research alternative, like reading and reporting on an article, or writing a brief paper. While the IRB may find this acceptable, the alternative must be equal to the research effort, for example, the alternative to a 10-question multiple choice survey should not be writing a 20-page paper; this would constitute undue influence to be in the research.

If the research activity also is purported to have an educational purpose, there should be a debriefing process where the student is provided information to understand the purpose, methodology, and results of the research.

One of the most challenging student research issues for IRBs is when the research is required for class credit or extra credit. In a student’s situation, this can certainly be considered undue influence to participate in the research. Non-research alternatives are critical to receive the same credit. This situation should be carefully reviewed and considered by the IRB to ensure the student’s rights are protected.

5. Safeguards for Privacy

Additional safeguards may be needed to protect the privacy interests of research participants when the participants are students. Classroom conditions may make it difficult for investigators to keep an individual’s participation confidential, which could pose risks to participants, e.g., when stigma is associated with the condition or question under study or when peer pressure is a component of the research. In such situations, consideration should be given to whether conducting the research off-site and/or outside of regular school hours may minimize potential risks.

Protecting the confidentiality of research participants’ personal information when the participants are students may also present additional challenges. The extent to which personal information and/or research data may be accessible to parents, teachers, or others not directly involved in the research must be considered and disclosed to potential participants and their parents/guardians (as applicable) in the informed consent and assent processes. (See again, CSS IRB SOP #16 Informed Consent w/ Checklist and Templates.)

In cases where regular classroom activities are also the topic of research, investigators must clarify for potential research participants (and/or their parents, as applicable) those activities that are optional and distinct from required classroom activities that would take place even without the research. When access to students or educational records is needed for recruitment and/or research activities, a letter of support from an individual authorized to speak on behalf of the institution (e.g., department chair, dean, etc.) may be required.

6. Family Educational and Rights Privacy Act (FERPA)

Certain additional protections for students and parents are provided by federal regulations. The proposed use of student education records for research must comply with the requirements of the Family Educational and Rights Privacy Act (FERPA). Please note that FERPA restricts researchers’ access to student records without written permission from parents of minor children, or permission of students over the age of 18. While some exceptions to FERPA may be available in a particular case, investigators must contact each institution in which they will be conducting research and follow that institution’s FERPA policy, in addition to the requirements of the IRB.

7. Protection of Pupil Rights Amendment (PPRA)

Protecting Student Privacy - U.S. Department of Education – Frequently Asked Questions https://studentprivacy.ed.gov/frequently-asked-questions

Research involving surveys with students in elementary and secondary schools that receive funding from the Department of Education must also comply with the Protection of Pupil Rights Amendment (PPRA) https://www2.ed.gov/policy/gen/guid/fpco/ppra/parents.html. Guidance on PPRA requirements can be obtained at https://www2.ed.gov/policy/gen/guid/fpco/ppra/parents.html.

The Protection of Pupil Rights Amendment (PPRA) applies to the programs and activities of a state education agency (SEA), local education agency (LEA), or other recipient of funds under any program funded by the U.S. Department of Education. It governs the administration to students of a survey, analysis, or evaluation that concerns one or more of the following eight protected areas:

  1. Political affiliations or beliefs of the student or the student’s parent;
  2. Mental or psychological problems of the student or the student’s family;
  3. Sex behavior or attitudes;
  4. Illegal, anti-social, self-incriminating, or demeaning behavior;
  5. Critical appraisals of other individuals with whom respondents have close family relationships;
  6. Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers;
  7. Religious practices, affiliations, or beliefs of the student or student’s parent; or
  8. Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).

PPRA also concerns marketing surveys and other areas of student privacy, parental access to information, and the administration of certain physical examinations to minors. (See again, CSS IRB SOP #26 Survey Research and Internet Research).

8. Psychology Subject Pool

The College of St. Scholastica students are offered the opportunity to be participants in research studies in various ways. Examples include participation for credit as part of a course requirement (e.g., Psychology Subject Pool), for credit in a course, or in exchange for payment.Unless the research is a class assignment in accordance with SOP 9, A CSS student may not be required to participate in research for course credit. In all cases, a comparable non-research alternative must be offered. To minimize the potential for coercion, alternatives to participating in research for course credit that are offered must be comparable in terms of time, effort, and fulfillment of course requirements.

All research participants, including students, must be free to withdraw from participation at any point in a study without penalty. Students who withdraw from a research study for course credit must receive full course credit for participation. When payment is offered, credit for payment accrues as the study progresses (as appropriate to the research) and is not contingent upon the student completing the entire study.

Study-specific informed consent is required as described by federal regulations and CSS IRB policies. Parental permission and assent are required for CSS students (including high school students taking CSS courses) who meet the regulatory definition of children.

9. Pertinent Laws and Regulations

It is the researcher’s responsibility to ensure the research design is compliant with applicable laws and regulations.

Federal Mandatory Reporting Law / Title IX

https://www2.ed.gov/about/offices/list/ocr/docs/tix_dis.html

Researchers have an obligation to report incidents of alleged sexual violence to the Title IX coordinator. The research design, including consent forms, must identify instances where confidentiality cannot be maintained.

State Mandatory Reporting Law

The research design must be compliant with state law where the research is conducted. The research design, including consent forms, must identify instances where confidentiality cannot be maintained. For example, mandatory reporting laws in Minnesota require a report of suspected child abuse or neglect.

Permission to use student assignments for research purposes

Example permission form:

I consider teaching a scholarly endeavor: what I learn from you in this class can help me improve future courses. I may even draw from your assignments to create scholarships that helps others wishing to improve their pedagogical (teaching) practices as well. If I do so, your identity (name or other identifiable information) will remain anonymous. If you have concerns, please speak with me.

Or, if the faculty member wishes to use more extensive info, direct quotes, etc. from assignments or reflection pieces, they could print and obtain signatures on a minimal informed consent statement:

Date: ____________

Purpose of Project:

Our unit on [topic] is a part of my ongoing scholarly project to investigate [research objective]. By signing this form, you give me permission to use your informal, reflective, and formal writing in my research on [topic]. For the examples I choose, I will be using pieces of your writing and you will be anonymous. If you don't wish to grant permission, that choice will not affect your grades in this course.

Name_______________________________________  (printed)

Name_______________________________________  (signature)

 

 

References:

45 CFR 46.116

45 CFR 46.116(a)(8)

OHRP Guidelines “What does it mean to minimize the possibility of Undue Influence / Coercion” https://www.hhs.gov/ohrp/regulations-andpolicy/guidance/faq/informed-consent/index.html University of Pittsburgh – Human Research Protection Office – Research Involving Students as Research Participants -

https://www.irb.pitt.edu/content/research-involving-students-research-participants IRB EasyEd, Research Involving Students, Volume 3 Number 9

Family Educational and Rights Privacy Act (FERPA) US Department of Education https://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html

PPRA Department of Education https://www2.ed.gov/policy/gen/guid/fpco/ppra/parents.html Protecting Student Privacy -U.S. Department of Education – Frequently Asked Questions

https://studentprivacy.ed.gov/frequently-asked-questions

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