email: hmaldonado@keuka.edu
The regulations require that the investigator seek consent only under circumstances that minimize the possibility of coercion or undue influence (45 CFR 46.116). 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 in order 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 in order 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)).
In addition, some research institutions use a so-called “student subject pool” to identify students who might be willing to participate in research, even when the exact nature of the research to be conducted has not yet been determined. Extra credits or other rewards are often offered as an incentive to encourage participation. 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. Thus, signing up to be in a subject pool is only a first and preliminary step by which individuals can indicate their willingness to be considered for research participation. The student must also provide informed consent, unless the consent requirement is waived by an IRB once he or she is being considered for a specific study (45 CFR 46.116). Furthermore, individuals in the pool must be free to decline participation in any available research projects without penalty (45 CFR 46.116(a)(8)).
(Source: Office for Human Research Protections Informed Consent FAQ's)
Please consider the following:
Students should not be used as a population of convenience for faculty/staff research.
In any proposed study that involves recruiting for research through classrooms, student listservs, or other student groups, clear explanation or justification should be provided as to why those students are the most appropriate participants for the study.
Permission must be obtained from the instructor of any Keuka College class/course where research activities may take place, including student recruitment. For research through student programs or services, permission from an appropriate administrator or faculty adviser should be requested. Documentation of support or permission may be required in the IRB review process.
Recruitment and consent of student subjects are not held to a different standard in the IRB review process, and the researchers must ensure that the recruitment and informed consent processes minimize the possibility of coercion or undue influence.
For recruitment of students through verbal scripts, fliers, listservs, and/or web-based systems for student subject pools, a brief description should provide information about the study purpose, procedures, and eligibility for individuals to take the next step towards the consent process. Use the Advertisement Worksheet (located on the Forms for Investigators page of this website) to help you determine if any research advertisements meet the criteria for approval.
Researchers must carefully consider the timing and the involvement of the instructor in any recruitment, consent process, or study procedures that will take place in a classroom setting.
Many research activities can be similar to or overlap with normal coursework or class projects. It is the researcher's responsibility to ensure that students can truly understand what participation involves and can distinguish voluntary research activities from required course activities.
When faculty propose to conduct research with students in their own classrooms or students that they directly oversee, the potential for coercion or undue influence increases and additional protections are required. In many cases, the involvement of a co-investigator or neutral third party may be an effective way to address perceived coercion or undue influence. Review the following section, taken from the Metropolitan State University of Denver Institutional Review Board website, for more detailed guidance :
Research with one’s own students presents unique considerations with regard to human subjects protections. At the center of the issue is the inherent power difference between student and instructor. Regardless how well a faculty member presents the recruitment and option not to participate, students may feel as though they have to participate or risk having their non-participation impact their grade or relationship with the professor. In addition, the idea of ongoing voluntary participation is a potential issue if a student decides they want to discontinue their participation after initially consenting. Real coercion is rare is research, but the perception of coercion can be just a problematic in obtaining voluntary informed consent.
The Keuka College IRB considers the following factors in support of proposed enrollment of subjects with potential status relationships with the researcher(s):
The research presents no greater than minimal risk to subjects.
The research represents a potential educational opportunity for participants.
The recruitment/consent language contain clear statements to address and minimize coercion and undue influence.
The recruitment and/or consent process will be conducted by someone who does NOT have a status relationship with the potential subjects.
If the research is conducted within the classroom setting, the instructor is blinded to the identity of participants - at least until grades are posted.
Examples for Avoiding Unintentional Coercion or Undue Influence in Classroom Settings
One method for avioding unintentional coercision or undue influence in the classroom setting is through the use a third party to distribute and collect consent and data. The third party may be an individual from the department office, another faculty member, or a co-investigator, etc. who has no relationship to these students or the course (i.e. not a co-instructor, teaching assistant, or student teacher). There are many variations to using this approach depending on the timing and procedures involved. Here are some examples of processes that can help minimize coercion of undue influence:
EXAMPLE A: Data will be collected from students in a targeted class through an anonymous survey (no names or other identifying information will be included). The researcher, who is also the instructor of the course, has designed a simple written consent statement to describe the research and no signed consent forms will be collected. At the end of a class period, the instructor/researcher introduces and discusses the study with the students (using the approved recruitment script and consent statement), answers any questions, and then leaves. A third party would distribute the survey to students and collect any completed surveys. The surveys could be provided to the instructor after all were collected. Using this process, the students can be assured that the instructor does not know who provided which survey and who did or did not participate.
EXAMPLE B: The survey administered to a targeted class is not anonymous (student names and IDs are being collected). The survey data will be linked to participating students' final exam scores and course grades. Here, the third party would be used the same as in the first example, but signed consent forms and identifiable surveys are collected and placed in a sealed envelope. The third party would keep the sealed envelope in a locked file cabinet until after the class grades were submitted. Only then are the completed consent forms and surveys provided to the instructor/researcher. The researcher will then know who has agreed to participate in the study and which survey they provided; but, the involvement of a third party and the timing provide students assurance that their participation, or lack thereof, has no impact on their grade or their standing in the class.
EXAMPLE C: An instructor proposes to use student work products (assignments, papers, quizzes, exams, etc.) as research data. Documented (signed) consent forms need to be collected from students who are willing to provide their data for the study. The instructor/researcher would present the study to the class and answer questions, as in the other examples. The third party would collect signed consent forms and keep them in a locked file cabinet until after the class grades have been submitted. Then, the faculty researcher could access the consent forms and collect and analyze only the work products of those students who had given permission to use for their data in the study. Again, in this process the students can be assured that their participation, or lack thereof, has no impact on their grade or their relationship with the instructor.
The specific role of the third party may or may not require them to be listed as a co-investigator on the IRB submission. Individuals who are tasked with obtaining consent (describing the study procedures, answering questions about the study, ensuring comprehension, etc.) are engaged in human research activities and are considered investigators by the IRB. Other individuals, like the third parties in the three example above, may only be tasked with collecting and temporarily holding documents for the investigators and generally are not themselves considered investigators on the study. How this process will work best for your study will depend on the procedures, the subject population, and other components of your specific research plan.
If you have questions on how to minimize the potential for coercion or undue influence in your research and who may be an investigator, please contact a member of the Keuka College IRB for guidance.