Herky Hints for HawkIRB: UI Students as Research Subjects
University Students as Research Subjects
FERPA Protections and Research at the UI
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Herky Hints for HawkIRB: UI Students as Research Subjects
By Rachel Kinker, MPA
When the researcher is an instructor and they intend to recruit students from their own classes, there are several safeguards that will need to be addressed in HawkIRB, including:
Plans for Recruitment: Recruitment methods* (such as having another instructor, not part of the research team, present recruitment information) that provide protection from coercion or undue influence.
Process for obtaining consent: Additional safeguards, such as having someone other than the investigator (instructor) obtain informed consent and collect the data.
Confidentiality and Privacy Protections: How the researcher/instructor will be blinded to student participation until after grades are posted. How students will be asked to respond to recruitment/consent processes in a manner that limits who knows whether or not they chose to participate in the research.
Management of Data/Responses: If the information from student participants is identifiable, the data collected should not be accessible to the investigator (instructor) until after grades have been assigned for the semester. This may be accomplished either by utilizing a “safe broker” to de-identify the data, or by having someone other than the investigator hold the data.
Related Sections of HawkIRB
Section VI: Description of the Subject Population
Section VI.18
If enrolling students as research subjects, select the ‘Yes’ option. By answering ‘Yes’ to VI.18, this will open question VI.19.
Section VI.19
In this question, provide a justification for using the student subject population and indicate how participation in the research is relevant to the course. The help message (blue icon circled in red below) provides helpful information to consider when adding the justification.
Section VII.D: Recruitment and Informed Consent
Section VII.D.12
When the investigator is the course instructor whose students will be recruited and consented for the project, the investigator should NOT be obtaining consent. Someone else from the research team (not in a position of authority over the students) should be named in section VII.D.12 to conduct the consent process.*
Section VII.D. 29
Provide a full description of recruitment methods in Section VII.D.29, including the precautions that the research team will take to minimize the potential for coercion or undue influence. These may include plans to:
Have someone other than the researcher/instructor conduct the recruitment process.
Provide information about the study in the syllabus (if applicable), in ICON, and/or through the student subject pool (SONA System).
Compensation - Section VII.E.14
If the research will be conducted under IRB-02 (social/behavioral research) and will offer course credit or extra credit as compensation for study participation, the researcher would indicate this in sections VII.E.14 & VII.E.15:
The description should indicate:
The amount of credit and whether it will be pro-rated
The plan to track participation and provide extra credit
Alternatives to study participation
That student compensation will not be penalized if they fail to show up for study visits without canceling by a specified deadline
[Note: Since it is less common for researchers in departments that submit to IRB-01 to offer credit/extra credit, the HawkIRB application for IRB-01 (biomedical research) does not contain Section VII.E.14 about offering course/class credit. If course credit or extra credit is the compensation plan for a study submitted to IRB-01, it should be described in sections VII.E.16 and VII.E.17.]
The response to Section VIIE.19 should provide a full description of the compensation plan for student subjects. Note: It is not necessary to duplicate the response if it was provided in one of the ‘description’ questions above.
Privacy Protections - Section X.1
Privacy protections described in HawkIRB X.1. should include how students can enroll or decline participation in a way that protects their privacy.
Management of Data/Confidentiality Protections - Section X.4
In section X.4, explain how and where data will be stored and who will manage the data until after grades are posted so the investigator is blinded to which students chose to participate.
Attachments
The following attachments or elements of attachments will need to be included, as applicable:
Syllabus - If an investigator wants to use UI educational records (i.e. a class assignment) for research purposes.
Signature section on consent document - To use educational records for research purposes, the researcher must obtain subject signature on the consent document – even if the project qualifies for Exempt Status and uses an Exempt Information Sheet.
Written permission from the UI Registrar - If utilizing educational records, the researcher must provide documentation of approval from the Office of the Registrar.
More information may be found in the UI Standard Operating Procedures and Researcher Guide Section II. part 7.K “Students as Subjects.”
FERPA regulatory requirements could impact research recruitment plan(s) proposed by the study team and those involved in the recruitment process. Review the article titled “FERPA Protections and Research at the UI.”
Questions about this topic? Email the HSO Education and Outreach team or come to Office Hours to speak directly to a member of the HSO team.
Have an idea for a future Herky Hint for HawkIRB? Let us know!
University Students as Research Subjects
By Emily Shultz, CIP
When a University of Iowa (UI) investigator is also an instructor recruiting students from their own class, the research plan must demonstrate consideration for the ethical concerns involved. The research plan should address the voluntary nature of the informed consent provided by students. To do this, the method of recruitment, the process of obtaining consent, and the timing of the investigator’s access to identifiers and research data must allow potential student participants to choose not to participate without concern over any potential penalty or consequences.
Coercion and Undue Influence
The IRB must ensure that the consent process is compliant with the Code of Federal Regulations for the Protection of Human Subjects
and
In the case of UI students as research subjects of an investigator who is also their instructor, a student could feel coercion if they perceive that their grades could be negatively affected if they chose not to participate. Undue influence could be involved if a student feels pressured to participate because their instructor is the investigator or because they think that all other students will be participating.
To minimize undue influence or coercion for research involving the investigator’s own students, i, the IRB will request the project has additional safeguards, such as
having someone other than the investigator conduct the recruitment/consent process,
keeping the instructor blinded to student participation until final grades are posted,
and providing a way for students to enroll or decline participation in a manner that protects their privacy.
Additional Institutional Policies
The UI Standard Operating Procedures and Researcher Guide, Part II, Section 7.K (Students as Subjects) provides detailed information about the protections that need to be in place for students as research subjects when the research compensation is provided in the form of course credit or extra credit. The investigator must:
Provide alternatives to participation in the research. These alternate activities must be comparable to the time commitment and effort of study participation.
Specify any prorating of credit or extra credit if students withdraw from the study prior to completion. The IRB favors giving credit, or prorated credit, even if the subject withdraws, unless the student withdraws immediately or there is clear evidence of bad faith on the part of the student.
Not penalize students who do not show up for the research study visit. Students will not receive research credit, but they cannot lose credits or points that they already received.
Note: If the research is a part of the course curriculum, the course syllabus should address it, and the syllabus should be submitted as an attachment in HawkIRB.
Students Who are Minors
If an instructor/researcher wishes to include UI students who are under the age of 18 in their sample, they will need to obtain parental permission. For minimal, or less than minimal risk research, the investigator may request a waiver of the requirement for parental consent.
If minor subjects will be enrolled, and a waiver is sought, the justification provided by the investigator in their HawkIRB application should include:
a detailed explanation of why obtaining parental consent for the minor subjects would not be practicable, and/or
scientific justification for why the inclusion of minors is necessary for the research.
“Not practicable” means that the research could not be done if the waiver is not granted. The term practicable comes directly from federal regulations under the requirements for waiver or alteration of informed consent (45 CFR 46.116(f)(3)(ii)
The IRB cannot grant this waiver just because the researcher does not have adequate staff to conduct the consent process, or they think potential subjects will not agree to participate. The waiver requires either a scientifically and/or ethically justifiable rationale.
HawkIRB Application
The descriptions that the PI will need to address in their HawkIRB application will include:
Plans for Recruitment:* Recruitment methods (such as having another instructor, not part of the research team, present recruitment information) that provide protection from coercion or undue influence.
Process for obtaining consent: Additional safeguards, such as having someone other than the investigator (instructor) obtain informed consent and collect the data.
Confidentiality and Privacy Protections: How the researcher/instructor will be blinded to student participation until after grades are posted. How students will be asked to respond to recruitment/consent processes in a manner that limits who knows whether they chose to participate in the research.
Management of Data/Responses: If the information from student participants is identifiable, the data collected should not be accessible to the investigator (instructor) until after grades have been assigned for the semester. This may be accomplished either by utilizing a “safe broker” to de-identify the data, or by having someone other than the investigator hold onto the data.
Conclusion
There are many ethical and regulatory considerations when the IRB reviews research with UI students as subjects. The recruitment and consent process, study procedures, compensation plans, and privacy and data security protections of the research will need to consider the data being obtained, and potential need for additional safeguards, written permissions, unique recruitment approaches and special consent requirements.
For more detailed information about the HawkIRB application, see IRB Connection article “Herky Hint for HawkIRB: Students as Research Subjects”
More information about students as research subjects may be found in the UI Standard Operating Procedures and Researcher Guide Section II. part 7.K “Students as Subjects.”
FERPA regulatory requirements could impact research recruitment plan(s) proposed by the study team and those involved in the recruitment process. Review the article titled “FERPA Protections and Research at the UI.”
Questions about this topic? You can email the HSO Education and Outreach team, or come to Office Hours to speak directly to a member of the HSO team.
Have an idea for an IRB Connection newsletter article? Let us know!
FERPA Protections and Research at the UI
By Emily Shultz, CIP
If an investigator wishes to conduct research that includes obtaining/utilizing educational records, they will need to adhere to the rules outlined under the Family Educational Rights and Privacy Act (FERPA). The University of Iowa (UI) Office of the Registrar FERPA Team oversees compliance with these regulations. The IRB works closely with the registrar’s FERPA team to make sure researchers comply with FERPA regulations.
FERPA regulations apply to the following educational records:
course enrollment or registration information, including class rosters
student work, including graded papers and exams
student transcripts
emails, notes, or online documents containing information about a student
Some directory information is available without consent. FERPA allows individual colleges and universities to specify what is considered “directory information” on their campuses. The University of Iowa defined the following data elements as public information unless the student restricts access:
1. Name
2. Residing address
3. Residing telephone number
4. Permanent/hometown address
5. Hometown and state
6. UI email address (@uiowa.edu) – See Reporting Correct Residential Address and E-mail Address Policy
7. University of Iowa HawkID
8. Programs of study (including but not limited to): majors, minor, certificates, classification, and degree objective)
9. College(s) enrolled in
10. Dates of attendance
11. Full-time/part-time enrollment status
12. Photographs and video recordings of students in public or non-classroom settings (photographs from classrooms or class-related activities are NOT directory information)
13. Participation in a study abroad program, not including location
14. Degrees, certificates, honors, scholarships, and awards received, not including monetary amounts, including those applied for during the current academic term;
15. Participation in officially recognized university activities and sports
16. Job title, employing department, work phone number, and work address when employed in a position that requires student status
17. Previously attended educational agencies or institutions
Students can restrict their directory information (items 2 through 6 above), their academic information (items 7 through 11 above), or both.
Special attention should be given to ensure the subject recruitment process complies with FERPA. No student educational records (e.g. class rosters, etc.) may be shared with individuals not otherwise affiliated with the academic course without student consent; this includes members of the study team. However, an individual not affiliated with the course may share an announcement about the research on ICON. In some circumstances, an individual not affiliated with the course may recruit subjects via a classroom presentation; please contact the Registrar’s Office FERPA Team for guidance on visitors to the classroom. See also Section II, Part 7.K. Students as Subjects in the UI IRB SOP & Researcher Guide.
Signed Consent - To use educational records for research purposes, the investigator must have signed consent from the student(s) and permission from the registrar. This is true even if the instructor already has access to the information and/or class assignments that will be used for the research study.
The informed consent document or exempt information sheet must be signed, for the purposes of FERPA. This is true even if the study is reviewed under an exempt category and would not otherwise require a signature.
Additionally, when researchers obtain informed consent for a study that involves FERPA data, the exempt information sheet, consent letter, or informed consent document must have a verifiable signature. The consent must also include an attestation statement that includes a checkbox confirming that the participant understands the use of FERPA information and agrees to participate in the research. (It is not sufficient for subjects to select “next” or “click here to continue” when using data under FERPA for research purposes.)
FERPA consent for disclosure of education records must:
include a unique identifier such as HawkID
have a verifiable signature with date,
specify the records that may be disclosed,
state the purpose of the disclosure, and
identify the party or class of parties to whom the records may be disclosed.
Researchers must keep a record of the written consent for six years after the close of the study.
University of Iowa Registrar Approval: The investigator must also obtain an approval memo from the University of Iowa’s Office of the Registrar FERPA Team for use of University of Iowa educational records. Email the registrar with the details and to request the approval memo. The PI must also attach the approval memo to the HawkIRB application.
Please review the recorded presentation in the IRB ICON Course for Researchers (under Additional Topics) for more information.
Additional information about FERPA and UI policies related to FERPA are available on the Registrar office’s website
