Vulnerable Populations Students as Subjects

• A principal investigator (PI) must acquire a Letter of Support from the principal of the school where the research is to be done before conducting research there.
• A Letter of Support must be submitted to the IRB for review. If the district of the school requires IRB approval before issuing a Letter of Support, please contact ORI for assistance.
• If the district has a Data Research Evaluation Board (e.g., Fayette, Scott, Jessamine Counties), include a copy of the district approval or support letter along with those of the schools involved. See the Off-Site Research webpage for guidance on possible additional requirements from school districts. 

• If non-UK school personnel, such as teachers or support staff, are assisting an investigator with their research, it may be necessary to list them as study personnel on the research protocol.  For example, a teacher distributing and collecting parent permission forms is engaged in research and will need to be added as study personnel.
• If a non-UK teacher or support staff member is acting as study personnel for a research project, they will need to sign an Individual Investigator Agreement (IIA). The investigator should contact the UK IRB Reliance Team to determine whether Individual Investigator Agreements (IIAs) are required.
• A K-12 teacher or support staff acting as study personnel on a research project will also need to complete Human Subject Protection (HSP) Training. A K-12 HSP Training Course is available for non-UK teachers and support staff acting as study personnel for research in a K-12 classroom. The course satisfies the requirements for Human Subject Protection (HSP) training for non-UK teachers and support staff. The investigator conducting research in a K-12 classroom is responsible for notifying the Office of Research Integrity (ORI) upon completion of the course. The course completion certificate, along with the study personnel's name and email address, should be emailed to the HSP Training Support team.

View the "IRB Study Personnel" webpage for more information

• Solicitation of student volunteers for research must be done in a non-coercive manner.  To avoid undue influence, participants should be recruited by a general announcement or a central posting/announcement mechanism.
• Recruitment advertising should include a clearly written description of the research project and a statement of the proposed student participation. The description and statement should be presented at a grade level appropriate to the student population being recruited.
• Recruitment advertising should also include the contact information of a neutral third party to contact should a student feel coerced at any time during the recruitment process.
• An invitation to participate in a research study should not require students or parents to send back a postcard or return a phone call if the student does not wish to participate. Students may become unwitting participants. For example, parents might never receive the letter. Or they may not read English. Or they may simply be confused by the instructions.

• Research involving minors (under 18 years of age) requires a signed parental permission in most instances as well as assent from the student (age 6-11 verbal, age 12-17 written). Some types of research may qualify for a Waiver of Parental Permission.
• If a parental permission form is sent home with a potential student participant, an investigator's contact information should be provided on the form to enable parents to ask any questions that they may have for the investigator.
• Requiring potential participants or a parent of potential participants to return a postcard or telephone call to opt out of a research study is called “passive” consent. The IRB only approves passive consent if the federal criteria for waiving informed consent are met. Passive consent also raises privacy concerns for certain types of research (e.g., research involving sexually transmitted diseases or psychiatric illness, or drug or alcohol abuse).
• Activities that are part of the research should be explained clearly in the parental permission and during the assent procedures. For instance, administering student interviews or questionnaires to assess classroom curriculum for research purposes is considered a research activity for which parental permission and assent are sought.
• Students have the right to full disclosure as soon as possible and throughout the ongoing consent process. 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 the intent of the researcher.
• Students must be allowed to withdraw from the study at any time. Any consequences for withdrawing from the research study prior to completion should be stated clearly with informed consent. In general, it is favorable to give credit if the participant withdraws, unless the student withdraws immediately or there is evidence of bad faith on the part of the student.
• Since there are heightened confidentiality risks in the closed environment of a classroom, special attention should be given to full disclosure of these risks with the consent of a student to participate in research.
• A program of instruction that is presented to the entire class in a conventional manner is not a research activity (even if it is novel), and parental permission forms should not imply that they are. However, individual student performance data that are part of the instruction can be included as research data with explicit permission and assent for additional use of instructional data.
• When extra credit is to be given to students who participate in research, students choosing not to participate in the research are to be given alternative options for extra credit. For example, short papers, special projects, book reports, and brief quizzes on additional readings, or completing a similar project. These projects should be comparable in terms of time, effort, and educational benefit to participation as research subjects to ensure that students are not being coerced into becoming subjects.  Alternative options offered to students choosing not to participate in the research study need prior IRB approval and should be noted during the consent process.
• For investigators 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 investigator 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 teacher). 

View the "Informed Consent" webpage for more information

• The plan for handling research data should be designed to minimize the risk that confidentiality will be breached.  For example, when instruments call for the disclosure of information that 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.
• When research activities to be done by the students are not part of the required class activities, the investigator should arrange to have the data collected by an independent third party, so that the investigator 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.
• 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.
• If the research project is one where data is collected from a group or 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.

The following are additional regulatory requirements, beyond the basic IRB rules, that may apply to research conducted in the K-12 setting:

The Family Educational Rights and Privacy Act (FERPA) is a federal law that protects the privacy of personally identifiable information contained within a student’s educational record. 

• FERPA applies to all schools (K-12, including postsecondary institutions) that receive funds under various programs from the U.S. Department of Education.
• Generally, investigators may not access classroom performance evaluations, grades, or information in a student’s records without prior written permission from a parent or authorized legal representative, regardless of the access an investigator may have in his/her academic role.
• An investigator who is also an employee in the school system should be aware that he or she may have access to student records as an employee, but does not have the same access as a researcher.
• Investigators should contact each institution where research is going to take place and follow that institution’s FERPA policy when accessing directory information.
• Refer to "FERPA Guidance (Research)" for guidance on complying with FERPA requirements when accessing educational records for research at UK.

The Protection of Pupil Rights Amendment (PPRA) requirements apply to surveys of students that reveal protected information of a sensitive nature. 

• PPRA outlines protections for DoED-funded surveys as well as surveys conducted in institutions that receive funds from any program of the DoED.
• Protections include allowing parental inspection of survey materials and parental permission (consent); therefore, PPRA impacts the determination of an IRB to waive elements of informed consent to allow ‘passive consent’.
• Refer to "PPRA Guidance (Research)" to ensure compliance with student survey research where applicable.

The U.S. Department of Education (DoED) is subject to additional requirements and ethical standards.  

• Refer to the Summary of Requirements for United States Department of Education (DoED) Supported Human Research for additional information.

The Children’s Online Privacy Protection  (COPPA), administered by the Federal Trade Commission, may apply to K-12 research conducted using online mechanisms.  If minors are recruited or are possibly in the recruitment pool, parental permission must be addressed.  Researchers are prohibited from collecting personal information from a child without posting notices about how the information will be used and without getting verifiable parental consent.

Prior to proposing research surveys, consider whether data is available from an existing public or institutional common data set. Repeated surveys with duplicative topics can contribute to survey fatigue, resulting in declining response rates and data quality. 

It is not acceptable to mandate student participation in research surveys. Nor should research surveys be disguised as mandatory quality improvement initiatives to improve response rates. 

Individual researchers are not positioned to directly affect institutional practice and bring about immediate change. Such initiatives should be conducted by and under the direction of Institutional Research, as it is in a position to coordinate efforts, prevent duplicative assessments, and aid the University in achieving strategic goals. See the UK ORI Research vs Quality Improvement guide for characteristics that differentiate and define the boundaries between these activities. 

Additional guidance on survey research

If research may involve disclosure of potentially risky situations or harmful circumstances, or address potentially distressful situations or topics, researchers are responsible for taking appropriate action to minimize these risks and provide referrals for care. 

Safeguards to minimize inherent risks to participation such as use of a certificate of confidentiality (CoC) to prohibit disclosure of information about illegal behaviors in response to legal demands; provision of counseling resources for research topics which may be distressing or upsetting; or referral for care in studies that inquire about suicide ideation or behavior should be included in the protocol (see UK ORI Suicide Guidance). 

To minimize potential undue influence, the course instructor should consider arranging to have the consent process and/or data collection performed by a third party (i.e., someone not directing the course content or assigning grades). 

If these are performed in person during a class session, the investigator should not be present. This prevents the instructor from knowing which students decided to participate in cases where the research involves or is related to coursework; the instructor should not have access to the information until after course grades have been assigned and entered for the semester.

In the social and behavioral sciences, course credit is commonly offered for research participation.

When course credit or extra credit is offered to students who participate in research, students should be given other options (e.g., alternative assignments such as short papers, special projects, book reports, additional readings, attending research seminars, etc.) to earn the same credit (see next section on alternatives). This requirement applies to any study in which an academic incentive is offered, including courses that require students to earn credits in a research subject pool.

Extra Credit Alternatives: Alternatives require IRB approval and should be comparable in terms of time, effort, and educational benefit to participation in the research study to ensure that students are not being coerced into participating in research. Additionally, such alternative options should award full credit for completion (i.e., not graded in such a manner that only partial credit may be given). Likewise, penalties and/or deductions in credit may not be applied if a student chooses to withdraw from a research study after enrolling (see OHRP determination letter).

Students should be of the age of majority in Kentucky (18 years old) to consent to participate in research. 

Research involving minors (i.e., those under 18 years of age, including 17-year-old college students) generally requires signed parental permission consent in addition to research assent from the student. [Assent Process] Some types of research may qualify for a Waiver of Parental permission; the IRB (in collaboration with legal input as needed) makes these determinations.

Considerations for the IRB when reviewing research protocols from the College of Education Early Childhood, Special Education, and Counselor Education programs

Some Master's degree students in the College of Education, and especially in the Early Childhood, Special Education, and Counselor Education program, face unique challenges with respect to recruitment for their degree-required research:

• These graduate students are typically employed full-time as primary or secondary level teachers and are studying behaviors of and/or strategies to use with students in an educational setting.
• This means that the research usually must be conducted during normal school hours, when it is difficult (if not impossible) for them to leave their own classrooms to conduct research.
• Additionally, if they are special education teachers, it might be that students in their own classrooms are the only students they have access to who display the behaviors relevant to the research.
• For these reasons, some education students may not have another practicable course of action other than to recruit students from their own class.
• Because these studies frequently employ single-case designs, the number of participants enrolled is typically very low. However, they are not case studies because these studies can be designed “to have strong internal validity for assessing causal relationships between interventions and outcomes, and external validity for generalizability of results” (Lobo et al., 2017).
• It is worth noting that these studies often present no greater than minimal risk and frequently have some chance of benefit for participants.

When researchers in the above situation are permitted to recruit students from their own classes, the IRB should likely expect the following:

• Greater than usual emphasis in the recruitment and consent process that the researcher is a student and that the study is part of the researcher's degree program.
• Greater than usual emphasis on the voluntariness of participation, including the ability to withdraw at any time.
• Greater than usual emphasis on consent and recruitment materials being easily understood by parents.

Citation:

Lobo, M. A., Moeyaert, M., Cunha, A. B., & Babik, I. (2017). Single-Case Design, Analysis, and Quality Assessment for Intervention Research. Journal of Neurologic Physical Therapy: JNPT, 41(3), 187–197. https://doi.org/10.1097/NPT.0000000000000187

Prior to conducting any research involving Chandler Medical Center residents/house officers as participants, the investigator must obtain the approval of the Graduate Medical Education (GME) Committee. Similarly, an investigator must obtain the approval of the Office of Medical Education (OME) before conducting any research involving University of Kentucky College of Medicine students.

IRB Application Information: Medical Center and/or College of Medicine residents or fellows as research subjects [F1.2500]

Generally, researchers may not access classroom performance evaluations, past or current grades, and/or information in a student’s records without written permission from the student, regardless of the access an investigator may have in his/her academic role. The Family Educational Rights and Privacy Act (FERPA) protects the privacy and confidentiality of personally identifiable information contained within student education records. 

Guidance on obtaining permission to access student records for research:

• FERPA Guidance (Research)
• FERPA | Office of the University Registrar (uky.edu) 

Resources for obtaining informed consent to use the accessed information for research purposes: 

• Assent Process 

[Note: this section pertains solely to student records and not to information or assignments/materials students provide for a specific course the researcher teaches/taught. Student permission is generally required for research use of those items as well as discussed in the next section.]

Information and materials university students provide as part of their expected and assigned coursework (e.g., completed class assignments, tests/quizzes, feedback/comments, etc.) should not be used for research purposes without their knowledge and permission. This primarily applies to situations in which the researcher is also the instructor/teaching assistant for the course, but can apply to other situations as well (e.g., researcher is a colleague/collaborator of the course instructor).

Whenever possible, researchers should avoid collecting research data during regular class sessions. 

When research participation consumes a significant portion of a class session, participants and non-participants all lose expected instructional time, which may be considered a loss of benefits and unfair (especially for those who chose not to participate in the research). 

Additionally, when research participation is “expected” during regularly scheduled class sessions, students may be unduly influenced to take part due to peer pressure, perceived stigmatization, consequences from non-participation, or a sense of having otherwise wasted time by attending that day’s class.

Since there are special risks of breaches of confidentiality in the close environment of the university, special attention should be given to full disclosure of such risks when consenting university students for research participation. 

In addition, the plan for collecting and handling research data should be designed to minimize potential breaches in confidentiality.  When data collection materials request the disclosure of information that participants may view as personal or sensitive, data should be collected in a manner that minimizes the chance that one participant could learn the response of another (e.g., students sitting close to/next to each other in a classroom, lab environment, etc.).

All research participants must be allowed to withdraw from a research study at any time. This includes student participants. 

As a result, the informed consent document/process should make clear any potential consequences of withdrawing from a research project prior to completion. In general, it is expected to award credit if the student withdraws from the research, unless the withdrawal is immediate (i.e., before any information/data is collected or provided) or there is evidence of bad faith on the part of the student.

If the research involves collecting data from a group project or recording (e.g., audio or video) of group interaction, consent from each student in the group is typically necessary for the use of data produced by the group in the research. In such cases, only data from consenting students can be used for the research; non-consenting student data must be effectively excluded (e.g., faces blurred, comments/feedback ignored, etc.).