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Human Subject Research

Guidance for enrolling University Students as Research Subjects & Using Student Subject Pools

In some research situations, use of students is integral to a research protocol. This is particularly true of research into teaching methods, curricula and other areas related to the scholarship of teaching and learning. In the social and behavioral sciences course credit is commonly offered for research participation.

An underlying principle of the regulations governing use of human subjects in research is that the subject's participation is voluntary and based upon full and accurate information. The student-teacher relationship raises the issue of volunteer participation. Students may volunteer to participate in the belief that doing so will place them in a favorable situation with faculty (e.g., better grade, good recommendation, employment possibilities), or that failure to participate will negatively affect their relationship with the investigator or faculty (e.g. lower grade, less favorable recommendation, being "uncooperative and not part of the scientific community).

Care should be taken to eliminate or reduce the risk that undue influence of faculty or coercion affects student participation in research. The following guidelines are offered to assist departments and faculty who engage in research projects in which students will be asked to be research subjects:

• Students should be of the age of majority in the state of Texas (18 years old). Research involving minors (under 18 years of age) as subjects, (16 or 17 year old college students) in most instances requires a signed parental (or legal guardian) consent, as well as the signed assent of the student. Some types of research may qualify for a Waiver of consent (parental permission).

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• Generally researchers may not access classroom performance evaluations, grades, and information in a (current) student’s records without prior written permission from the student, regardless of the access an investigator may have in his/her academic role.

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• When research activities to be done by the students are not part of the required class activities, the instructor should arrange to have the data collected by an independent third party, so that the instructor does not know who participated and does not have access to the identifiable data or identity of participants for any purpose until grades have been assigned and entered. For instructors using pre- and post- tests to determine efficacy of a particular curriculum, a colleague or third party should obtain the consent forms and distribute the tests when the instructor is not present (a graduate teaching assistant in the class in which the student/subject is enrolled does not qualify as a third party for collecting the data on behalf of the instructor).

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• When course credit or extra credit is given to students who participate in research as part of a course requirement, students are to be given other options for fulfilling the research component, for example; short papers, special projects, book reports, and brief quizzes on additional readings, research seminars, or completing a similar project. These projects must be comparable in terms of time, effort and educational benefit to participation as a research subject to ensure that students are not being coerced into becoming subjects. Alternatives offered to student subjects need prior IRB approval. Departments seeking to use student subject pools and offering projects including pre- and/or post-testing also require IRB approval.

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• Solicitation of volunteer student subjects for research must be done in a non-coercive manner. To avoid undue influence, subjects should be recruited by a general announcement, central posting or announcement mechanism and should include a clearly written description of the project and a statement of the proposed student participation. In addition to being provided with the traditional information and consent forms, the student should also be provided with the name and contact information of a neutral third party to contact should they feel coerced at any time during the process.

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• Whenever possible, researchers should avoid data collection during regular class meetings. When study participation consumes a significant portion of a class section, loss of instructional time for both participants and non-participants may be considered a loss of benefits. Also when research participation is expected during the same session at which participation is invited students may be unduly influenced to take part due to peer pressure, perceived stigmatization from non-participation, or a sense of having otherwise wasted time by attending that day’s class.

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• Since there are special risks of confidentiality in the close environment of the university, special attention should be given to full disclosure of these risks in the consenting of a student to participate. The plan for handling consent forms and research data should also be designed to minimize the risk that confidentiality will be breached (e.g., signed consent forms can be collected and filed separately from the anonymous test instrument). When instruments call for the disclosure of information which participants may view as personal or sensitive, data should be collected in a manner that minimizes the chance of one participant learning the response of another.

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• The use of mass testing (classroom scenario) is strongly discouraged. Whenever possible, students should be allowed to access web-based research related activities via designated or personal computers. Using an application such as, Experimetrix is also desirable because it allows the student to register for participation in specific research activities outside of the view of others at the time and place of their choosing.

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• Like other research volunteers, students who become research participants must be allowed to withdraw from the study at any time. The informed consent statement should make clear the consequences of withdrawing from a project prior to completion. In general it is favorable to give credit if the subject withdraws, unless the student withdraws immediately or there is evidence of bad faith on the part of the student.

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• If the research is one where data are collected from a group project or perhaps a videotape of the group interaction, each student’s consent is necessary for the use of that data in the instructor’s research. If one student does not consent, the data may be used only if the non-consenting student’s data can be effectively excluded.

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• When deception is used students have the right to full disclosure as soon as possible. Two consenting presentations are required, the first of which will normally take place during the pretesting period; the final informed consent will be presenting at the debriefing. Whenever possible a teaching opportunity in the form of an "educational debriefing" should be employed. Students should know something about the rationale for the study, the process of data collection, and intent of the researcher. In exceptional circumstances, the full or true purpose of the research may not be revealed to the subjects until the completion of data collection. In such cases, students must not be subjected to undue stress or embarrassment and must have the right to full disclosure of the purpose of the study as soon as possible after the data have been collected. During the debriefing students must be given an opportunity to decide whether the researcher(s) can use the data collected.

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• Research conducted by graduate students in a class in which the researcher teaches, assists in the class or does any grading should be subject to the same restraints described above.

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• Refer to the Sample Informed Consent for Pretesting (template).

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• INDIVIDUAL (UNAFFILIATED) INVESTIGATORS (non-UTA employees) seeking to enroll UTA students into human subject research protocols must contact the Office of Research Integrity & Compliance by calling (817) 272-0834. Prospective enrollment of UTA students into research without the written approval of the UTA Institutional Review Board is strictly prohibited. Refer to the policy and SOP regarding, “Individual Investigators.”

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DEPARTMENTAL CONSIDERATIONS
When Using Student Subject Pools

1. What is a Subject Pool?

a. Chance for students to earn credit
b. Opportunity for students to learn about the experiences of human subject research
c. Easy recruitment method for investigators

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2. What are the Issues Surrounding the Use of Subject Pools?

a. Voluntary participation
b. Research volunteer versus student rights of participation
c. Coercion (mass testing)
d. Breach of confidentiality
e. IRB oversight
f. Institutional Responsibilities

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3. Maintaining Documentation of Participation

a. Maintaining records to obtain credit
b. Maintaining data records
c. Maintaining records to document payment per IRB reporting requirements

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4. What are the IRB Responsibilities for the Use of a Subject Pool?

a. Satisfactory risk/benefit ratio
b. Equitable selection of subjects
c. Satisfactory informed consent process
d. Presence of coercion due to mass testing
e. Comparable alternative activity(s)
f. Adequate privacy and confidentiality guarantee

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5. What are the Main Risks in Using Subject Pools?

a. Coercion due to in-class (mass) testing
b. Breach of Confidentiality
c. Lack of comparable alternative activity(s)
d. Position as a research participant overrides position as student, during research participation 6. How to Minimize Risks a. Comparable alternatives
b. Sign-in form kept separate from consent form (agreement with institution/department)
c. Must be able to withdraw at any time without penalty
d. Use of anonymous, minimal risk studies
e. Appropriate role of undergraduates as research staff
f. Exclude students <18 years of age; or (if exclusion is not appropriate), assent student and consent legal parent or guardian, or
g. Students <18 years of age may participate (e.g., for the education or experience), but their data cannot be used in the research

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7. Parental Consent and Child's Assent for Participation

a. All subjects must consent
b. Parents must give permission for minors

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8. Requirements for the Use of Subject Pools

a. Only exempt or minimal risk research will be permitted
b. Parental consent for those under 18, if the data is intended for research use
c. Students fully informed of their rights as participants
d. Documentation of participation to receive credit remains separate from documentation for participation in the research
e. Studies must have IRB approval prior to initiation
f. Must provide comparable alternatives
g. Decrease presence of coercion

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9. Recruitment vs. Informed Consent

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10. Special Issues in Prescreening and Database Management of Subject Pools

a. Student access to student (identifiable) information
b. Privacy and confidentiality

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GUIDANCE & HELPS