Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number:  25
Effective Date:  10/8/2021

Policy

This policy addresses ethical issues that researchers should be aware of when designing the rationale for their use of a focus group as well as the use of video, audio and digital recordings.  Application template, FERPA Addendum , and sample informed consent documents are attached at the end of this SOP.

Purpose

In the course of designing a research project, researchers may deem a focus group as the best way to gather data from several participants in a short amount of time. Focus groups are an important method for data collection in qualitative research.  The use of video, audio, and digital recordings are other means of collecting data. While they offer many advantages to both researchers and research participants, they also raise some unique ethical concerns.

Participant Information

When research involves the use of focus groups to obtain data, the participants should be given information before the focus group takes place regarding:

• what the topic is,
• who the other participants / stakeholders may be,
• risks and benefits of participation,
• the manner and form in which data will be collected and confidentiality maintained, ● where the group will meet, and ● how long the session will last.

Participants should be informed about the topics that will be discussed so that they may make an informed decision to participate beforehand. This is especially important for research that will engage sensitive topics and are considered more than minimal risk.

In the consent form and during the consent discussion, participants should be informed of who may participate in the focus group.  Ideally this would be done during the recruitment phase, throughout the consent discussion and in the consent form.  A participant may decide that he/she does not want to participate based on the expected other participants in the group.

Confidentiality

The researcher must provide participants with the procedures in place to maintain confidentiality of the research data. Researchers cannot guarantee confidentiality to focus group participants.  Whether or not contributions to the focus group discussion remain confidential depends on the willingness of other participants in the focus group to respect that confidentiality.

In the consent form and during the consent discussion, participants should be informed that the information shared in the focus group session should not be shared with anyone outside of the group, and that the confidentiality of anything they choose to say during the session cannot be guaranteed.  If the focus group is being audiotaped, participants should be instructed to maintain their privacy and confidentiality, and that of the people they talk about, they should not use names.

Sensitive Issues

It is particularly important to inform participants ahead of time when sensitive topics will be discussed (e.g., sexuality, substance abuse).  Focus groups addressing sensitive topics may raise some social risks for participants that cannot be well controlled by the researcher.  For example, participants in the focus groups may respond to each other in ways that are painful, embarrassing, angering, or frustrating for other participants.

Regardless of whether the CSS IRB considers a protocol minimal risk or requires full board review, there are features the IRB can require in research procedures and consent forms that can add safety options when needed. For one, interviewers should receive training in general human research protection as well as study-specific training on the assessment and management of emotional distress. This may include the development of, and training on, safety scripts outlining procedures to be used when problems occur during the interview. Furthermore, if subjects need help or counseling as a follow-up to the research, the consent form should include information to contact the principal investigator or counselors or other resources which explicitly states to contact them to offer help when the research has caused emotional distress which requires attention. These services should be readily available should a subject call. Consent form safety language and available services may not be required for every survey or interview, but the IRB should consider whether or not they should require them when reviewing research involving surveys or interviews which includes sensitive topics. If the investigator does not provide safety information in the consent form, the IRB must consider crafting template language and making it available to the investigator.

Risks Related to Sensitive Issues

In general, when a focus group is discussing a topic which is not sensitive (for example, taste or brand preferences), there is less concern about confidentiality and social risk. For research that is minimal risk, adding a paragraph to the informed consent detailing issues of confidentiality for focus groups may suffice.

On the other hand, as the sensitivity of the topic of the discussion increases, so do the steps that researchers should take to protect subjects.   The following is a list of CSS IRB guidelines aimed at reducing ethical concerns raised by the use of focus groups:

• Researchers should offer a clear research-based justification for using focus groups rather than some other lower-risk method for obtaining the information.   The level of justification required is proportionate to the level of sensitivity of the topic.
• The risks associated with the focus group must be outweighed by the benefits obtained through the focus group.  Focus groups discussing highly sensitive research topics should only be led by highly skilled researchers with the training necessary to lead the discussion effectively and analyze the results meaningfully.  IRB applications which include a proposal to use focus groups should provide evidence of the appropriate CITI training of the researcher conducting the focus group.  Additional training recommendations include:
  1. Receive training in general human research protection as well as study-specific training on the assessment and management of emotional distress;
  2. Development of, and training on, safety scripts outlining procedures to be used when problems occurs during the interview, and;
  3. If subjects need help or counseling as a follow-up to the research, the consent form should include information to contact the principal investigator or counselors or other resources which explicitly states to contact them to offer help when the research has caused emotional distress which requires attention.
• All focus group participants should participate in an informed consent process which includes a section asking participants to respect each other’s confidentiality, while also acknowledging that the researcher can’t guarantee complete confidentiality.

Consent form safety language and available services may not be required for every survey or interview. The CSS IRB reviewer should consider whether or not the study under review requires these additional safety recommendations.

Research involving topics that may cause greater than minimal distress or confidential information that could place a participant at risk if disclosed are considered sensitive topics.  Any interview, survey, or questionnaire that proposes to investigate opinions, behaviors, and/or experiences regarding – but not limited to – any of the following sensitive topics require full IRB review and approval:

▪      Sexual orientations, sexual harassment, sexual assault, sexual molestation or abuse, incest, practices of contraception, abortion, and/or pregnancy;

▪      Substance use and/or abuse including, but not limited to, alcohol, marijuana, steroids, amphetamines, narcotics, any prescription medication legally or illegally obtained;

▪      Questions regarding mental health (e.g. suicide, depression, obsessive-compulsive disorders, drug use, underage drinking, gambling, and/or eating disorders);

▪      Traumatic experiences (e.g. being a victim of violence, child abuse, senior abuse, war or conflict experiences, (see, CSS IRB SOP #9 Student Class Assignments v Research).

Audio and Video Recordings

In cases where the focus group session will be audio- or videotaped, the PI must disclose use of recording devices in the consent form and as part of the consent discussion.  When the focus group meets, the PI should again disclose this to each member of the focus group and ask if they agree to be audio- or videotaped.  If being taped is a requirement of participation in the focus group, this must be stated in the consent form.  If a member of the focus group objects to being taped, the PI can excuse the participant from the group, or agree not to audio- or videotape the session.  Video editing tools that blur or block individual participants may also be used and described in the protocol application.  Participants should be given the opportunity to withdraw their consent AFTER the focus group session has ended.  All of these specifics regarding videotaping must be clearly stated in the consent form.

Participants should also be informed about what will be done with these recordings. If audio or video from the focus groups will be used for something other than data analysis for the approved protocol (i.e. – future research studies, educational purposes, conference presentations, etc.) then participants must explicitly agree to this in the form of a checked box agreeing to or not agreeing to have their video/audio used for the above purposes in the consent form.

Because audio, video or digital recordings include images or voices of research participants, they pose a greater concern to the IRB than do data that do not have readily available identifying information. Therefore, to best protect research participants, the CSS IRB requires that any such recordings be destroyed within five years following the making of the recordings, five years after data are collected, unless the participant gives permission to archive for future research in the current consent form.

Although recordings are not specifically addressed in 45 CFR 46 the consent process is clearly defined and holding recordings indefinitely and/or for an unspecified purpose challenges the spirit of informed consent and has the potential to increase risk to participants (e.g., breach of confidentiality, damage to reputation, legal ramifications). To be in line with informed consent and to minimize risk, participants must be informed (in the informed consent form) about the destruction timeframe, as well as informed about who will have access to the recordings and where they will be stored.

FAQs on Photos and Videos under FERPA  (U.S. Department of Education – Protecting Student Privacy)

FERPA (Family Educational Rights and Privacy Act)is a Federal law that is administered by the Family

Policy Compliance Office (Office) in the U.S. Department of Education (Department). 20 U.S.C. § 1232g; 34 CFR Part 99. FERPA applies to all educational agencies and institutions (e.g., schools) that receive funding under any program administered by the Department. Parochial and private schools at the elementary and secondary levels generally do not receive such funding and are, therefore, not subject to FERPA. Private postsecondary schools, however, generally do receive such funding and are subject to FERPA.

Once a student reaches 18 years of age or attends a postsecondary institution, he or she becomes an "eligible student," and all rights formerly given to parents under FERPA transfer to the student. The eligible student has the right to have access to his or her education records, the right to seek to have the records amended, the right to have control over the disclosure of personally identifiable information from the records (except in certain circumstances specified in the FERPA regulations, some of which are discussed below), and the right to file a complaint with the Department. The term "education records" is defined as those records that contain information directly related to a student and which are maintained by an educational agency or institution or by a party acting for the agency or institution.

(See, Addendum A at the end of this document.)

Archiving Recordings for Future Research

Because the IRB recognizes the potential value in archiving recordings for future research, if an investigator wishes to archive recordings, the IRB requires the following information to consider the request:

1. Included in the application must be sound justification for archiving recordings indefinitely.
2. The informed consent form must include the following:

● A statement indicating where and how recordings will be stored, secured; ● A statement indicating who will have access to recordings; ● Space for participants to indicate whether they:

• Want recordings to be destroyed by the 5 year timeframe specified, or
• Permit the recordings to be archived for future research within a given research area (e.g., language development, spatial perception, conversational attributes). PLEASE NOTE: The application may need to be reviewed at the Full Board Review level, allowing the IRB to decide collectively whether or not archiving the recordings increases risk to participants.

Using Archived Recordings for Secondary Data Analysis

Any proposed use of already-archived recordings (i.e., secondary data analysis) must be reviewed by the CSS IRB. A copy of the informed consent form from the original study must be submitted with the protocol application.

If the IRB finds that the purpose of the secondary data analysis is related to the purpose of the original study and the material in the recordings does not put the participant at risk, the application for secondary data analysis is likely to undergo an Expedited Review.

If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study or the material in the recordings could put the participants at risk, the application for secondary data analysis is likely to undergo a Full Board Review. The Full Board IRB will determine whether or not secondary analysis of the recordings increases risk to participants and whether or not participants were adequately informed during the original study about the use, confidentiality, and destruction of their recordings. Based on these findings, the IRB may require that informed consent for secondary analysis is obtained from participants.

Use of Research Recordings for Educational Purposes or Presentation Purposes

The use of these segments must be clearly defined in the informed consent form and participants must have the option of whether or not they consent to such uses of the recordings. For example:

______I agree that segments of the recordings made of my participation in this research may be used for conference presentations.

______I do not want segments of the recordings made of my participation in this research to be used for conference presentations.

______I agree that segments of the recordings made of my participation in this research may be used for education and training of future researchers/practitioners.

______I do not want segments of the recordings made of my participation in this research to be used for education and training of future researchers/practitioners.

Once segments have been chosen, the remainder of the recordings must be destroyed (unless approved for archiving). Segments cannot be used for purposes beyond those detailed and consented to in the informed consent form.

Consent

Sample Consent forms are attached to this SOP.

Resources

IRB EasyEd. Do sensitive research questions cause emotional distress and harm?  Volume 1 Number 10.

© 2017 Apex Ethical

Fort Lewis College IRB -Durango  Guidelines for Focus Groups. https://www.fortlewis.edu/administrative-offices/committees/college-committees/institutional-review-b oard/institutional-policy-and-guidelines/guidelines-for-focus-groups University of Massachusetts – Amherst – Focus Group Research https://www.umass.edu/research/guidance/focus-group-research

University of Massachusetts – Amherst – Audio/Video/Digital Recordings of Research Participants https://www.umass.edu/research/guidance/audio-recordings-research-participants?_ga=2.233939550.1

101445142.1583787299-1605214739.1583787299 University of Connecticut Focus Groups https://ovpr.uconn.edu/services/rics/irb/researcher-guide/focus-groups/ Clemson University.    Focus Group Consent Form Suggested Format

https://www.clemson.edu/assessment/documents/Consent%20to%20Participate%20in%20Focus%20Gr oup.pdf

Fordham University – Informed Consent (Focus Group Research)

https://www.fordham.edu/download/downloads/id/2431/sample_informed_consent_-_focus_group_0 214doc.pdf

University of Missouri Kansas City – Sample Verbal Consent Script http://ors.umkc.edu/docs/irb/sample-consent-verbal-script.doc

UC Davis Office of Research- Template Protocol SURVEYS/INTERVIEWS AND/OR FOCUS GROUPS: use in conjunction with the online Initial Review Application form when no sponsor authored protocol is available https://research.ucdavis.edu/policiescompliance/irb-admin/researchers/irb-forms/#Templates University of Colorado Boulder IRB

https://www.colorado.edu/researchinnovation/sites/default/files/attached-files/focus_group_guidelines _-_final_17apr17.pdf

U.S. Department of Education – Protecting Student Privacy – FAQs on Photos and Videos Under FERPA https://studentprivacy.ed.gov/faq/faqs-photos-and-videos-under-ferpa

Boston Children’s Hospital – IRB Manual - Guidelines for Research Funded by Department of Education and School Based Research http://www.childrenshospital.org/-/media/Research-and-Innovation/Office-of-Clinical-Investigation/202 0---IRB-Policies-and-Procedures-Manual/irbm-011-003-funded-ED.ashx?la=en&hash=EEE239FAD2072B7

E76B992B48BD07EE00A1FB09BU.S

U.S.Department of Education – FERPA General Guidance for Students https://www2.ed.gov/policy/gen/guid/fpco/ferpa/students.html#:~:text=Private%20postsecondary%20s chools%2C%20however%2C%20generally,FERPA%20transfer%20to%20the%20student.

Addendum A

FAQs on Photos and Videos under FERPA  (U.S. Department of Education – Protecting Student Privacy)

FERPA (Family Educational Rights and Privacy Act) is a Federal law that is administered by the Family

Policy Compliance Office (Office) in the U.S. Department of Education (Department). 20 U.S.C. § 1232g; 34 CFR Part 99. FERPA applies to all educational agencies and institutions (e.g., schools) that receive funding under any program administered by the Department. Parochial and private schools at the elementary and secondary levels generally do not receive such funding and are, therefore, not subject to FERPA. Private postsecondary schools, however, generally do receive such funding and are subject to FERPA.

Once a student reaches 18 years of age or attends a postsecondary institution, he or she becomes an "eligible student," and all rights formerly given to parents under FERPA transfer to the student. The eligible student has the right to have access to his or her education records, the right to seek to have the records amended, the right to have control over the disclosure of personally identifiable information from the records (except in certain circumstances specified in the FERPA regulations, some of which are discussed below), and the right to file a complaint with the Department. The term "education records" is defined as those records that contain information directly related to a student and which are maintained by an educational agency or institution or by a party acting for the agency or institution.

Researchers frequently wish to conduct research in schools. Some of this research may be funded by the Department of Education which has specific requirements when using education records according to the Family Educational Rights and Privacy Act (FERPA). Research may consist of observation in classrooms, interviews with teachers, questionnaires given to students, video or audio taping of classrooms, focus groups or interviewing parents about their children. Schools may also be used as a recruitment site for posting notices of research activities.

Any research that is to be conducted in a school setting must be submitted and reviewed in accordance with the CSS Institutional Review Board policies and procedures. Upon submission it may be determined that a protocol is exempt from review or requires expedited or full committee approval. The Institutional Review Board will request a copy of an approval notification from authorized individuals within the school or school district. Investigators are required to comply with the schools' policies and procedures for all proposed research. Different school systems may have different procedures and the investigator is obligated to contact the school district and develop their protocol consistent with the school policies. For any research conducted by CSS that involves a request for access to educational institution student records without parental permission/student consent, responsibility for complying with FERPA specific parent/student consent exception requirements, including requirements for removal of all personally identifiable information, will be the responsibility of that educational institution.

1. When is a photo or video of a student an education record under FERPA?

As with any other “education record,” a photo or video of a student is an education record, subject to specific exclusions, when the photo or video is:  (1) directly related to a student; and (2) maintained by an educational agency or institution or by a party acting for the agency or institution. (20 U.S.C. 1232g(a)(4)(A); 34 CFR § 99.3 “Education Record”).

Directly Related to a Student:

FERPA regulations do not define what it means for a record to be “directly related” to a student. In the context of photos and videos, determining if a visual representation of a student is directly related to a student (rather than just incidentally related to him or her) is often context-specific, and educational agencies and institutions should examine certain types of photos and videos on a case by case basis to determine if they directly relate to any of the students depicted therein. Among the factors that may help determine if a photo or video should be considered “directly related” to a student are the following:

• The educational agency or institution uses the photo or video for disciplinary action (or other official purposes) involving the student (including the victim of any such disciplinary incident);
• The photo or video contains a depiction of an activity:
  • that resulted in an educational agency or institution’s use of the photo or video for disciplinary action (or other official purposes) involving a student (or, if disciplinary action is pending or has not yet been taken, that would reasonably result in use of the photo or video for disciplinary action involving a student); o that shows a student in violation of local, state, or federal law;
  • that shows a student getting injured, attacked, victimized, ill, or having a health emergency;
• The person or entity taking the photo or video intends to make a specific student the focus of the photo or video (e.g., ID photos, or a recording of a student presentation); or
• The audio or visual content of the photo or video otherwise contains personally identifiable information contained in a student’s education record.

A photo or video should not be considered directly related to a student in the absence of these factors and if the student’s image is incidental or captured only as part of the background, or if a student is shown participating in school activities that are open to the public and without a specific focus on any individual.

Examples of situations that may cause a video to be an education record:

• A school surveillance video showing two students fighting in a hallway, used as part of a disciplinary action, is directly related to the students fighting.
• A classroom video that shows a student having a seizure is directly related to that student because the depicted health emergency becomes the focus of the video.
• If a school maintains a close-up photo of two or three students playing basketball with a general view of student spectators in the background, the photo is directly related to the basketball players because they are the focus of the photo, but it is not directly related to the students pictured in the background. Schools often designate photos or videos of students participating in public events (e.g., sporting events, concerts, theater performances, etc.) as directory information and/or obtain consent from the parents or eligible students to publicly disclose photos or videos from these events.
• A video recording of a faculty meeting during which a specific student’s grades are being discussed is directly related to that student because the discussion contains PII from the student’s education record.

Maintained by an educational agency or institution:

To be considered an education record under FERPA, an educational agency or institution, or a party acting for the agency or institution, also must maintain the record. Thus, a photo taken by a parent at a school football game would not be considered an education record, even if it is directly related to a particular student, because it is not being maintained by the school or on the school’s behalf. If, however, the parent’s photo shows two students fighting at the game, and the parent provides a copy of the photo to the school, which then maintains the photo in the students’ disciplinary records, then the copy of the photo being maintained by the school is an education record.

Exclusion for Law Enforcement Unit Records

The FERPA statute and regulations (20 U.S.C. 1232g(a)(4)(B)(ii) and 34 CFR §§ 99.3 and 99.8) exclude from the definition of education records those records created and maintained by a law enforcement unit of an educational agency or institution for a law enforcement purpose. Thus, if a law enforcement unit of an educational agency or institution creates and maintains the school’s surveillance videos for a law enforcement purpose, then any such videos would not be considered to be education records. If the law enforcement unit provides a copy of the video to another component within the educational agency or institution (for example, to maintain the record in connection with a disciplinary action), then the copy of the video may become an education record of the student(s) involved if the video is not subject to any other exclusion from the definition of “education records” and the video is:  (1) directly related to a student; and (2) maintained by an educational agency or institution or by a party acting for the agency or institution.

2. Can the same recorded image be the education record of more than one student under FERPA?

Yes. For example, a surveillance video that shows two students fighting on a school bus that the school uses and maintains to discipline the two students, would be “directly related to” and, therefore, the education record of both students.

 

3. If a video is an education record for multiple students, can a parent of one of the students or the eligible student view the video?

When a video is an education record of multiple students, in general, FERPA requires the educational agency or institution to allow, upon request, an individual parent of a student (or the student if the student is an eligible student) to whom the video directly relates to inspect and review, or "be informed of" the content of the video, consistent with the FERPA statutory provisions in 20 U.S.C. § 1232g(a)(1)(A) and regulatory provisions at 34 CFR § 99.12(a). FERPA generally does not require the educational agency or institution to release copies of the video to the parent or eligible student.

In providing access to the video, the educational agency or institution must provide the parent of the student (or the student if the student is an eligible student) with the opportunity to inspect and review or "be informed of" the content of the video. If the educational agency or institution can reasonably redact or segregate out the portions of the video directly related to other students, without destroying the meaning of the record, then the educational agency or institution would be required to do so prior to providing the parent or eligible student with access. On the other hand, if redaction or segregation of the video cannot reasonably be accomplished, or if doing so would destroy the meaning of the record, then the parents of each student to whom the video directly relates (or the students themselves if they are eligible students) would have a right under FERPA to inspect and review or "be informed of" the entire record even though it also directly relates to other students.

4. If a video is an education record for multiple students, can the parent of one of the students (or theeligible student) receive a copy of the video?

While we do not advise on an educational agency’s or institution’s obligations under any state open records laws that may apply, we note that FERPA does not generally require an educational agency or institution to provide copies of education records to parents and eligible students. That said, it would not violate FERPA for an educational agency or institution to non-consensually disclose to an eligible student or to his or her parents copies of education records that the eligible student or his or her parents otherwise would have the right to inspect and review under FERPA.

5. If redaction or segregation of an education record of multiple students can be reasonably accomplished without destroying the meaning of the education record, can educational agencies and institutions charge parents or eligible students for the costs of the redaction or segregation?

No. FERPA provides parents and eligible students with the right to inspect and review the student’s education records, and nothing in the FERPA statute or regulations permits educational agencies and institutions to charge parents or eligible students for fees or costs associated with exercising that right.

If a school elects to provide a parent or eligible student with a copy of the education records, then the FERPA regulations (34 CFR § 99.11(a)) generally permit (with the exception noted below) the school to charge for the costs required to make the copy. FERPA regulations (34 CFR § 99.11(b)) also provide that the school may not charge a parent or eligible student for the costs to search for or retrieve the education records. We view the costs, if any, to the school of redacting, or segregating, education records of multiple students as being like the costs of search and retrieval that may not be charged to parents or eligible students, rather than like the costs for copies that generally may be charged to parents and eligible students. As noted above, if an educational agency or institution can reasonably redact or segregate out portions of an education record that is directly related to other students, without destroying the meaning of the record, then the educational agency or institution must do so and therefore cannot charge parents or eligible students for the costs associated with exercising their right to inspect and review such education records.

In contrast, parents and eligible students generally may be charged for the costs of making copies of education records precisely because FERPA generally does not require the school to provide them with such copies. Thus, where the redaction or segregation of education records of multiple students can be reasonably accomplished without destroying the meaning of the education records, nothing in FERPA permits educational agencies or institutions to charge parents or eligible students for the costs of making the required redactions or segregation. Please note that the FERPA regulations (34 CFR § 99.11(a)) similarly provide that if a fee for copies effectively prevents a parent or an eligible student from exercising the right to inspect and review his or her education records, an educational agency or institution would be required to provide copies without payment. Such cases would be limited to a parent or an eligible student providing evidence of the inability to pay for the copies due to financial hardship.

6. Does FERPA permit legal representatives of parents or eligible students to inspect and review videoswith the parent or eligible student?

Yes. FERPA permits legal representatives of a parent or an eligible student to inspect and review videos with the parent or eligible student. While FERPA does not require educational agencies and institutions to allow parents or eligible students to bring their attorney or other legal representative with them when they exercise their right to inspect and review the student’s education records, nothing in FERPA prevents educational agencies and institutions from allowing parents or eligible students to bring their attorney or other legal representative with them when they exercise their right to inspect and review the student’s education records under FERPA.

7. Does FERPA permit educational agencies and institutions to turn over videos to the police uponrequest or following an incident that may warrant police involvement?If the law enforcement unit of an educational agency or institution creates and maintains videos for a law enforcement purpose, then the videos would not be education records and FERPA would not prohibit the law enforcement unit of an educational agency or institution from disclosing the videos to the police. If the videos are education records, however, educational agencies and institutions may not turn over videos to the police upon request without having first either obtained the written consent of the parent or eligible student or determined that the conditions of an exception to the general requirement of consent have been met, such as if the disclosure is made in connection with a health or safety emergency (20 U.S.C. 1232g(b)(1)(I) and 34 CFR §§ 99.31(a)(10) and 99.36) or the law enforcement officer has presented the educational agency or institution with a judicial order or a lawfully issued subpoena (20 U.S.C. 1232g(b)(1)(J) and (b)(2) and 34 CFR § 99.31(a)(9)).

The Individuals with Disabilities Education Act (IDEA) also contains privacy protections that apply to children with disabilities. 20 U.S.C. 1417(c) and 34 CFR §§ 300.610-300.626 and 34 CFR §§ 303.401-303.416. Under the IDEA, participating agencies must protect the personally identifiable information (PII), data, or records that are collected, maintained, or used by the participating agency. While the definition of “education record” under Part B of the IDEA cross-references the FERPA definition in 34 CFR § 99.3, the application of IDEA requirements may raise different questions.

If circumstances effectively prevent the parent or eligible student from otherwise exercising their right to inspect and review the student’s education records (e.g., if the parent lives outside of commuting distance to the school), then the educational agency or institution would be required to either provide a copy of the records or to make other arrangements for the parent or eligible student to inspect and review the records. 34 CFR § 99.10(d)

 

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INSTRUCTIONS FOR RESEARCH INVOLVING SURVEYS/INTERVIEWS AND/OR FOCUS GROUPS: use in conjunction with the online Initial Review Application form when no sponsor authored protocol is available.

This template is for research that involves surveys, interviews, and focus groups. If your proposed project involves any activities other than surveys, interviews or focus groups, do not use this form.

Please take the time to read all italicized instructions and questions.

Delete the italicized instructions before submitting to the IRB.

Depending on the nature of what you are doing, some sections may not be applicable to your research. If so, mark as “N/A” or delete.

Protocols that involve only interviews, surveys or focus groups are exempt from the requirement for IRB oversight if they meet the following requirements:

• The research will not ask for information that could place an individual at risk or criminal or civil liability or could be damaging to the participants’ financial standing, employability or reputation; or
• The research will ask for information that could place an individual at risk or criminal or civil liability or could be damaging to the participants’ financial standing, employability or reputation the responses will be collected in a manner that the participant cannot be identified directly or through any indirect identifiers (such as a code or pseudonym that is linked to the individual’s identity);

 

Objectives

Describe the purpose, specific aims, or objectives.

 

State the hypotheses to be tested.

Background

Describe the relevant prior experience and gaps in current knowledge.

Describe any relevant preliminary data.

Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge.

Indicate the procedures that you will use to collect data.

☐ Surveys – Attach all surveys you will use in this study.

☐ Interviews – Attach an interview script with the questions that will be asked during the interview.

☐ Focus groups – Attach a summary of the questions and issues that will be discussed during the focus sessions.

☐ Observation of public behavior – Describe the behavior you will be observing below.

Click here to enter text.

☐Other – Describe any other data collection or research procedures you will be conducting

Click here to enter text.

Will you record any information that directly or indirectly identifies the individual on the data collection form (survey, interview responses or documentation of observations)?

☐ Yes – Provide justification for recording identifiers. In other words, why do you need to record the identifiers?

Click here to enter text.

☐ No

☐ I am collecting data through more than one survey, interview or observation.

Responses obtained from only the following will include direct or indirect identifiers:

Click here to enter text.

Participants' will be:

☐ Audiotaped

☐ Videotaped

Recordings will be labeled with direct or indirect identifiers: _☐ Yes _☐ No

Data Management and Confidentiality

☐ I understand that if this study involves use of CSS students’ educational records (including records in the PI’s own possession such as course exams/assignments), I must ensure all requirements of the Family Educational Rights and Privacy Act (FERPA) are satisfied by completing the CITI module on FERPA.  

Indicate how you will protect the data that you obtain and/or the information you record while conducting this study from disclosure to any individual who does not have a right or a need to access the information (check all that apply)

☐ Individual’s responses/statements will not be linked to their identity. (No identifying information will be included on the documents/recordings and the

documents/recordings will not be coded and linked to the individual’s identity.)

☐ Individual’s responses/statements will not include any information that identifies the individual, but the responses/statements will be coded and linked to their identity on a separate document or in a separate database.

☐ All identifiable electronic data will be maintained on an encrypted device requiring a password for access. Passwords will not be shared and will be protected from access.

☐ If the research includes review of medical or education records, such identifiable information will be stored on an encrypted device or password protected files. Investigators will follow applicable CSS FERPA and HIPAA policies.

☐ All paper records will be stored in a locked room/file-cabinet with access limited to only individuals who have a right and need for access.

☐ Other – (e.g. how will you manage the confidentiality for visual images and/or audio/video tapes?)  Describe Click here to enter text.

Inclusion and Exclusion Criteria

Inclusion Criteria:

Click here to enter text.

Exclusion Criteria:

Click here to enter text.

Age Range:

Click here to enter text.

Study Timelines

The duration anticipated to enroll all study subjects for prospective data collection only:

☐ I will be enrolling subjects until: Click here to enter text.

Click here to enter text.

The estimated date for the investigators to complete this study (complete primary analyses):

Click here to enter text.

Data Banking

Will data be banked for future use? ☐ Yes ☐ No

Note - If data will be banked for future use, the aims of the study must justify the retention of the data and you will need to address the additional questions below and the consent form must indicate that data will be banked for future use.

If yes, will the data that are banked be identifiable?

☐ Yes, the data will be identifiable

☐ No, the data will be completely anonymous.

☐ No, the data will be stripped of identifiers and will be coded.  The link to the individual’s identity will not be made available to those requesting data from the data bank and will be maintained separately from the data bank.

Where will the data be stored?

Click here to enter text.

How long will the data be stored?

Click here to enter text.

Who will have access to the data?

Click here to enter text.

Describe the procedures to release data, including: the process to request a release, approvals required for release and who can obtain data.

Click here to enter text.

Risks to Subjects

☐ This data collection study poses the risk of loss of confidentiality.  The risk will be minimized through the processes described above. This study will abide by all applicable law, regulations, and standard operating governing the protection of human subjects, student information and protected health information.

☐ Other – Describe:

Click here to enter text.

Potential Benefits to Subjects

☐ The participants who complete surveys or participate in interviews, focus groups or observation of public behavior are not likely to receive any benefit from the proposed research but others may benefit from the knowledge obtained.

☐ Other – Describe:

Click here to enter text.

Sharing of Results with Subjects

☐ Results will not be shared with subjects.

☐ Results will be shared with subjects – Describe:

Click here to enter text.

Review Requirement

Are there any contractual obligations or other considerations that require IRB review of this research, or review at intervals other than those required by the Common Rule or FDA? If yes, check box:

⬜ Yes

⬜ No

Important note about consent for exempt research - If this study meets the requirements for an exemption, you may use an abbreviated process for obtaining consent.  Consent can be verbal, but you must provide the following information to participants through an information sheet or written script:

• The subject is being asked to participate in a research study;
• A description of the procedure(s) the participant will be asked to complete;Participation is voluntary; and
• The investigator’s name and contact information.

(Template courtesy of UC Davis Office of Research)

 

Informed Consent [SAMPLE FOCUS GROUP RESEARCH]

Study Title

You are invited to participate in a research study about PURPOSE OF STUDY. This study is being conducted by NAME AND AFFILIATION OF RESEARCHERS. FUNDING SOURCE has provided funding for this study. You are invited to participate in this study because STATE WHY INDIVIDUAL WAS SELECTED

Participation in this study is voluntary. IF RELEVANT, INCLUDE: 1) WHO WILL KNOW, OR NOT KNOW THAT THEY PARTICIPATED; 2) NOT PARTICIPATING WILL NOT AFFECT ANY BENEFITS, SERVICES, ETC. RECEIVED NOW OR IN THE FUTURE.

If you agree to participate in this study, you will participate in a focus group [DEFINE THIS OR USE

ANOTHER TERM, E.G. GROUP DISCUSSION, AS APPROPRIATE TO THE STUDY SAMPLE] with WHO ELSE

WILL BE IN FOCUS GROUP. The focus group will be led by …. The topics that will be discussed during the focus group include…. The focus group will last ## minutes/hours.

The focus group will be audio and/or video recorded in order to accurately capture what is said.  You may choose how much or how little you want to speak during the group. You may also choose to leave the focus group at any time.

If you participate in the study, you will receive FILL IN THE INCENTIVE for your time. You will also receive FILL IN (E.G., INFORMATION, RESOURCE LIST, ETC.).

Participating in this study may not benefit you directly, but it will help us learn …. We do not envision any significant risks related to participation in this study. Participants may feel some pressure to reveal feelings or experiences to the group. If participants share their experiences with colleagues and peers, they may also feel vulnerable during or after the group.

The information you will share with us, if you participate in this study, will be kept completely confidential to the full extent of the law. Participants will be asked not to use any names during the focus group discussion. Please be advised that although the researchers will take every precaution to maintain confidentiality of the data, the nature of focus groups prevents the researchers from guaranteeing confidentiality. The researchers would like to remind participants to respect the privacy of your fellow participants and not repeat what is said in the focus group to others.

Non-Disclosure Statement

____I agree to maintain the confidentiality of the information discussed by all participants and researchers during the focus group session.

If you cannot agree to the above stipulation, please see the researcher(s) as you may be ineligible to participate in this study.

Reports of study findings will not include any identifying information. Audio-recordings of the focus groups will be kept on a password-protected computer in Dr. [FACULTY NAME]’s locked office. After the focus group recording is typed it will be destroyed. The typed transcription will be kept on the password-protected computer and any printed copies will be kept in a locked file cabinet in Dr. NAME’S locked office. Only LIST NAMES OR TITLES/AFFILIATION will be able to listen to the recording or read the typed version of the recording.

IF IT IS LIKELY THAT THE FOCUS GROUP STUDY INVOLVES A SENSITIVE RESEARCH TOPIC THAT MAY TRIGGER AN UNWANTED EMOTIONAL RESPONSE (E.G. SEXUAL, CHILD OR SPOUSAL ABUSE, ALCOHOLISM, TEEN PREGNANCY, SEXUALITY, STDs, ETC.) the following should be included:

< >Ensure services or counseling are made available;Include a crisis hotline number if available; orThe contact information for other counseling services available to subjects both during and after their participation. IF IT IS LIKELY THAT CHILD ABUSE OR NEGLECT MAY BE REVEALED DURING THE FOCUS GROUP, INCLUDE THE FOLLOWING: The only exception to the protection of confidentiality is if you talk about the abuse or neglect of a child by yourself or someone else, in which case the SOCIAL WORKER / OTHER MANDATED REPORTER is required by Minnesota State law to report this to appropriate authorities. This may result in an investigation to determine if the child or children you talked about are being abused or neglected.

 

The CSS IRB requires that any audio/video/digital recordings be destroyed within five years following the making of the recordings or five years after data are collected unless the informed consent form states otherwise.

Because the CSS IRB recognizes the potential value in archiving recordings for future research, if an investigator wishes to archive recordings, the IRB requires the following information to consider the request:

                      1.   The informed consent form must include the following:

● A statement indicating where and how recordings will be stored, secured; ● A statement indicating who will have access to recordings; ● Space for participants to indicate whether they:

< >Want recordings to be destroyed by the timeframe specified, orPermit the recordings to be archived for future research within a given research area (e.g., language development, spatial perception, conversational attributes), orPermit the recordings to be archived indefinitely.Any proposed use of already-archived recordings (i.e., secondary data analysis) must be reviewed by the CSS IRB. A copy of the informed consent form from the original study must be submitted with the protocol application.

 

Use of Research Recordings for Educational Purposes or Presentation Purposes

The use of these segments must be clearly defined in the informed consent form and participants must have the option of whether or not they consent to such uses of the recordings. For example:

______I agree that segments of the recordings made of my participation in this research may be used for conference presentations.

______I do not want segments of the recordings made of my participation in this research to be used for conference presentations.

______I agree that segments of the recordings made of my participation in this research may be used for education and training of future researchers/practitioners.

______I do not want segments of the recordings made of my participation in this research to be used for education and training of future researchers/practitioners.

Once segments have been chosen, the remainder of the recordings must be destroyed (unless approved for archiving). Segments cannot be used for purposes beyond those detailed and consented to in the informed consent form.

If you have any questions about this study, please contact [NAMES OF PIs, PHONE NUMBERS AND EMAIL ADDRESSES]. If you have questions about your rights as a research participant, please contact Dr. Steve Cope, CSS IRB Chairperson, The College of St. Scholastica IRB at (email) and (office phone).

Your signature on this consent form indicates your agreement to participate in this study.

You will be given a copy of this form to keep, whether you agree to participate or not.

The second signed consent form will be kept by the researcher.

I have read the consent form and all of my questions about the study have been answered. I understand that the focus group will be recorded. I agree to participate in this study.

________________________	____________________	__________
Participant Signature:	Print Name:	Date:

By signing below, I indicate that the participant has read and, to the best of my knowledge, understands the details contained in this document and has been given a copy.

_________________________	____________________	__________
Signature of Person Obtaining Consent	Print Name:	Date:

This sample is a template from which a verbal consent script can be developed. Please modify it as needed.  Since the presentation is verbal, the script may be somewhat shorter but should still include the required elements of consent. The consent script should be written in simple terms understandable to the subject. Information provided in italics needs to be filled in and the italics deleted.

SAMPLE VERBAL CONSENT SCRIPT

I am [name of investigator], from The College of St. Scholastica [departmental affiliation and status; if student, indicate that you are working on your thesis or dissertation ]. I am conducting a research study on [state topic of research].  The research will help me understand [state expected benefits to participants and to society from this research].

Today you will be participating in a [individual phone interview, focus group, etc.], which should take approximately [state time needed to complete activity]. Your participation is voluntary. If you do not wish to participate, you may stop at any time. Responses will be [describe confidentiality procedures – e.g. responses will be completely anonymous; your name will not appear anywhere in the final write up; I will assign you a pseudonym, etc.]. There are minimal risks associated with this [activity]. Taking part in this [activity] is your agreement to participate.

[If this is a group interview, the following language needs to be included: “During the group interview, I will not be able to guarantee confidentiality because we will be discussing information as a group. Therefore, if you would feel uncomfortable with any of your statements being shared with others in or outside the group, please do not share them during the process.]

If you would like a copy of this letter for your records, please let me know and I will [give you a copy now; email, mail, or fax it to you, etc.]. If you have any questions regarding the research, contact [give name, department, phone number, and department address if applicable. Include advisor name/phone if student, and identify as advisor]. If you have any questions regarding your rights as a research subject, please contact the CSS IRB Chair at irb@css.edu.

NOTE: If data collection involves audiotape/videotape of activities, any verbal script must advise subjects that the activities will be audiotaped/videotaped and discuss the disposition of tapes (i.e., where stored, how long they will be kept and when they will be destroyed).

The CSS IRB requires that any such recordings be destroyed within a definitive time frame (e.g., five years following the making of the recordings, five years after data are collected).

Because the CSS IRB recognizes the potential value in archiving recordings for future research, if an investigator wishes to archive recordings, the IRB requires the following information to consider the request:

                      1.   The informed consent form must include the following:

< >A statement indicating where and how recordings will be stored, secured;A statement indicating who will have access to recordings;Space for participants to indicate whether they:Want recordings to be destroyed by the time frame specified, orPermit the recordings to be archived for future research within a given research area (e.g., language development, spatial perception, conversational attributes).Any proposed use of already-archived recordings (i.e., secondary data analysis) must be reviewed by the CSS IRB. A copy of the informed consent form from the original study must be submitted with the protocol application.

 

Use of Research Recordings for Educational Purposes or Presentation Purposes

The use of these segments must be clearly defined in the informed consent form and participants must have the option of whether or not they consent to such uses of the recordings. For example:

______I agree that segments of the recordings made of my participation in this research may be used for conference presentations.

______I do not want segments of the recordings made of my participation in this research to be used for conference presentations.

______I agree that segments of the recordings made of my participation in this research may be used for education and training of future researchers/practitioners.

______I do not want segments of the recordings made of my participation in this research to be used for education and training of future researchers/practitioners.

Once segments have been chosen, the remainder of the recordings must be destroyed (unless approved for archiving). Segments cannot be used for purposes beyond those detailed and consented to in the informed consent form.

(Courtesy of University of Missouri Kansas City – Sample Verbal Consent Script)