IRB Information and FAQs

A project generally requires IRB review when it:

1. Is a systematic investigation designed to develop or contribute to generalizable knowledge; and
2. Involves living individuals from whom researchers obtain information or biospecimens through interaction or intervention, or obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens.

Common examples include surveys, interviews, focus groups, experiments, observations, educational interventions, analysis of identifiable student or employee records, and collection of biological or physiological information.

Not every activity involving people is considered human subjects research. Some classroom exercises, internal program evaluations, quality-improvement activities, journalism projects, and projects using publicly available or fully deidentified information may fall outside IRB oversight. However, the purpose, methods, intended use of the results, and identifiability of the information all affect the determination. Researchers should not make their own official determination that a project is exempt or does not require IRB review. Contact the Lindenwood IRB at [email protected] before beginning the activity when there is any uncertainty.

Possibly. Publication is one indication that a project may be intended to contribute to generalizable knowledge, but it is not the only consideration. Presentations, conference posters, theses, dissertations, grant reports, public reports, and plans to apply findings beyond the immediate program may also indicate that an activity is research.

Conversely, an activity does not automatically become research solely because someone later wishes to present or publish the results. The IRB evaluates the project’s original purpose, design, and intended use of the information.

When publication or presentation is a possibility, researchers should consult the IRB before collecting data. The IRB cannot provide retroactive approval for research that has already occurred.

Activities conducted only to assess or improve a specific program, service, course, or institutional process do not meet the regulatory definition of research. However, a project may require IRB review when it is designed to test a hypothesis, compare interventions, produce broadly applicable conclusions, or disseminate findings as research.

Because quality improvement, program evaluation, assessment, and research can overlap, investigators should request an IRB determination before beginning the project when the results may be presented, published, or used beyond the program being evaluated.

It may. IRB review may be required when researchers receive or use identifiable private information, coded information that can be linked to individuals, student education records, medical information, employment records, or other nonpublic data.

A project involving only publicly available information or data that are fully deidentified before the researcher receives them may not constitute human subjects research or may qualify for an exemption. The IRB must evaluate how the data were obtained, whether identifiers or codes exist, who can access the linking information, and whether individuals could reasonably be reidentified.

Researchers must also obtain any required permission from the office, school, organization, or data owner that controls the records. IRB approval does not replace FERPA, HIPAA, contractual, institutional, or data-owner requirements.

Yes, when the information was not originally collected under an IRB-approved research protocol or when you are proposing a new research use. Data collected for teaching, assessment, employment, clinical care, or administrative purposes do not automatically become available for research. Contact the IRB before beginning the research analysis. The IRB will consider the original purpose of the data, participant

Exempt research is human subjects research that fits one or more specific exemption categories established by federal regulations. Common examples may include certain anonymous or low-risk surveys, interviews, educational tests, observations of public behavior, or secondary research using qualifying information. “Exempt” does not mean that the project is exempt from ethical responsibilities or institutional oversight. Researchers must submit the project to the IRB and receive an exemption determination before beginning the research.

Expedited review applies to certain research activities that involve no more than minimal risk and fit an approved federal expedited-review category. Despite its name, “expedited” describes the review procedure – not a guaranteed faster turnaround time. The application is reviewed by the IRB chair or one or more experienced IRB reviewers rather than discussed by the convened board.

Full-board review is generally required when a study involves more than minimal risk or includes procedures, populations, or circumstances that do not qualify for exempt or expedited review. The study is reviewed at a convened IRB meeting and must receive approval from a majority of the voting members present.

The IRB – not the researcher – makes the final determination regarding the appropriate review category.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.

Risk is not limited to physical harm. The IRB also considers psychological, social, legal, financial, educational, employment, reputational, and privacy risks.

No. At Lindenwood, researchers must submit the project through Cayuse and receive a written exempt determination before beginning the research. Researchers may not independently designate their projects as exempt.

Review time depends on the type and complexity of the study, the completeness of the application, the researcher’s response time, and the IRB’s review schedule.

As a general planning guide:

• Exempt determinations frequently take approximately one to three weeks.
• Expedited reviews frequently take approximately two to four weeks.
• Full-board reviews may take four to eight weeks or longer, depending on meeting dates and required revisions.

These are estimates rather than guaranteed timelines. Incomplete applications, missing attachments, inconsistent information, or missing CITI training can substantially delay review. Full-board studies should be submitted well before the meeting at which the researcher hopes the project will be reviewed. Review timelines may be longer during the summer because IRB staffing and board-member availability are limited.

It depends on the purpose and planned use of the activity.

A classroom exercise may not require IRB review when it is conducted solely to teach/learn research methods, the results remain within the classroom, the activity is not designed to contribute to generalizable knowledge, and there is no intention to present, publish, archive, or use the results for a thesis, dissertation, conference, or other research purpose.

IRB review is generally required when student work is intended to produce research findings, involves systematic data collection from people, will be disseminated beyond the classroom, may contribute to a thesis or dissertation, or may later be used as research.

Instructors should contact the IRB for a Non-Human Subjects Research Determination (NHSR) before assigning a class-wide project when there is uncertainty. A classroom project cannot be retroactively approved after data have been collected.

Routine course evaluations or assessments conducted only to improve a course or academic program may not require IRB review. Review may be required when the activity is designed as a systematic research study or when the results will be analyzed and disseminated as research.

Additional protections may be necessary when an instructor studies their own students because of the instructor’s authority over grades, recommendations, or academic standing.

Recruiting one’s own students creates a potential for undue influence or a perception that participation could affect grades or the student-instructor relationship. Such recruitment may be permitted only when appropriate safeguards are included.

Safeguards may include:

• Recruitment or consent conducted by someone other than the instructor;
• Delaying the instructor’s access to participation information until after final grades are submitted;
• Providing a comparable nonresearch alternative when research participation is connected to course credit;
• Clearly stating that participation is voluntary and will not affect grades or standing; and
• Avoiding recruitment during circumstances in which students may feel pressured to participate.

The application must clearly explain the instructor’s role, how participants will be recruited, who will obtain consent, and how participation information will be separated from grading decisions.

Yes. Student-led research must be supervised by an eligible Lindenwood faculty advisor. The faculty advisor is responsible for helping ensure that the application is accurate, complete, methodologically appropriate, and compliant with IRB requirements.

Students should work with their advisors before submitting. Applications that have not been carefully reviewed by the faculty advisor may be returned for additional development.

Yes, student-led projects should list the student as the PI. However, student researchers must identify their faculty advisor and obtain the advisor’s certification before the application can proceed. Contact [email protected] with questions about the appropriate study-team roles.

Lindenwood uses Cayuse IRB for human subjects research applications, determinations, modifications, renewals, incident reports, and study closures. Researchers should review the Cayuse instructions and required IRB materials before beginning an application.

Do not begin recruitment, consent, data collection, or research analysis until the required written IRB approval or determination has been issued.

For questions about the content of an application, required documents, research design, consent language, review category, or IRB requirements, contact the Office for Research and Creative Activity at:

[email protected]

For technical problems with the Cayuse platform – such as system errors, loading problems, or functions that are not working as expected – visit Cayuse Support or submit a ticket to the Cayuse Help Desk.

When requesting help, include the study title, study number if available, a brief description of the problem, and a screenshot of any error message. Do not email sensitive participant information.

Common reasons include:

• A required question or attachment is missing;
• A member of the research team has not completed certification;
• The faculty advisor has not certified a student application;
• Required CITI training is missing or expired;
• The study team member’s institutional information is incomplete;
• The application contains validation errors; or
• An earlier workflow step has not been completed.

Review the application’s completion indicators and certification status. Contact [email protected] when the reason is unclear.

Certification is the electronic confirmation that the information in the application is accurate and that the person agrees to fulfill their responsibilities as a member of the research team. Adding a person to the study does not automatically complete their certification. Each person whose certification is required must log in and complete the certification step.

Yes. Faculty, staff, students, advisors, and other research personnel who are engaged in human subjects research must complete the appropriate CITI human subjects protection course before IRB approval.

Researchers should complete the course that corresponds to their field:

• Social-Behavioral-Educational Research; or
• Biomedical Research.

Additional modules may be required depending on the project, funding source, sponsor, or research responsibilities. Training must remain current throughout the study.

List individuals who will have responsibility for the design or conduct of the study. This generally includes people who will:

• Recruit or consent participants;
• Interact or intervene with participants for research purposes;
• Collect research data;
• Access identifiable private information;
• Analyze identifiable or coded data;
• Make decisions about study procedures; or
• Supervise the conduct of the research.

Individuals whose activities are limited to routine administrative support or who receive only fully deidentified data may not need to be listed. Contact the IRB when a person’s role is unclear.

Lindenwood’s IRB Forms and Templates webpage includes materials such as:

• Adult consent forms;
• Adult consent on behalf of a minor;
• Minor assent forms;
• Exempt research information sheets;
• Non-identifiable survey information sheets;
• Identifiable survey consent forms; and
• Classroom project information sheets.

Researchers should use the template that corresponds to the study population, review category, data collection method, and level of identifiability.

Templates should be adapted to accurately describe the specific project. Remove instructions and sample language that do not apply. Consent templates that have not been adapted to the specific project or that still contain template instructions, prompts, or sample language will be returned for revision, as IRB approval is based on the consent form appearing in Cayuse exactly as it will be presented to participants.

A consent form typically includes a signature or other documentation of consent. An information sheet contains the information participants need to make an informed decision but does not require a signature.

The appropriate format depends on the project, review category, risks, population, and whether the IRB approves a waiver of signed documentation. Researchers should not omit signatures merely because an unsigned process is more convenient.

Submit all materials that participants will see or that will be used to conduct the study, as applicable. These may include:

• Consent forms and information sheets;
• Parental permission and minor assent forms;
• Recruitment emails, flyers, scripts, posts, and advertisements;
• Screening questions or scripts;
• Surveys and questionnaires;
• Interview or focus-group protocols;
• Experimental instructions and debriefing materials;
• Letters of cooperation or site permission;
• Data-use agreements;
• External IRB approval documents;
• Grant protocols or sponsor materials; and
• Permission to use restricted instruments.

The application and attachments must describe the same procedures. Inconsistencies between documents are a common cause of revision requests.

Yes. Recruitment emails, flyers, scripts, social-media posts, registry language, and other participant-facing advertisements must be included in the application and approved before use.

Recruitment materials should accurately describe the study, eligibility criteria, time commitment, location or format, compensation, and contact information without overstating benefits or minimizing risks.

IRB approval does not automatically authorize access to institutional email lists, courses, departments, student groups, records, or campus locations. Researchers must obtain any required administrative or site permission.

Campus-wide recruitment involving Lindenwood students may require College or Provost-level approval. Upload evidence of required permission to Cayuse when requested.

No. Recruitment is part of the research process. Researchers may not distribute recruitment materials, screen potential participants, obtain consent, collect data, or begin research procedures until written approval or the required determination has been issued.

Yes, external collaborators may be included when their roles are clearly described and appropriate institutional requirements are met. External team members who are engaged in the research may be required to:

• Be listed in the Cayuse application;
• Complete human subjects protection training;
• Provide their institutional affiliation and contact information;
• Obtain approval from their own institution;
• Sign an individual investigator agreement or other assurance document; or
• Be covered by an IRB reliance or authorization agreement.

Cayuse access for an external collaborator may require additional account setup. Contact [email protected] before submission for assistance.

Lindenwood studies must have an eligible Lindenwood-affiliated investigator responsible for the University’s conduct of the research. External individuals ordinarily cannot use the Lindenwood IRB solely because they need access to an IRB.

Do not begin Lindenwood-related research activities based only on the external approval letter. Contact the Lindenwood IRB and provide:

• The external IRB approval letter;
• The approved protocol or application;
• The approved consent and recruitment materials;
• The external institution’s contact information;
• A description of the Lindenwood personnel and their responsibilities;
• The locations where research activities will occur;
• The funding source, if applicable; and
• Any proposed reliance or authorization documents.

The Lindenwood IRB will determine whether Lindenwood must conduct its own review, acknowledge the project, or enter into an agreement to rely on the external IRB. Reliance arrangements establish which IRB will provide regulatory review and how responsibilities will be divided between the institutions. External approval does not automatically extend to Lindenwood or its personnel.

A reliance agreement – sometimes called an IRB authorization agreement – is a written agreement under which one institution relies on another institution’s IRB for the review and continuing oversight of a specific study or group of studies.

The agreement identifies the reviewing IRB, the relying institution, and the responsibilities retained by each organization. These may include local training requirements, conflict-of-interest review, reporting of problems, management of institutional requirements, and communication with the reviewing IRB.

Reliance must be approved by the institutions. Researchers may not independently decide that one institution will rely on another.

Contact the IRB early in the planning process. Serving as the reviewing IRB may require reliance agreements, communication plans, site-specific information, local-context review, reporting procedures, and coordination among all participating institutions.

Reliance arrangements can take time to establish and should be addressed before recruitment or data collection begins at any relying site.

No. The reviewing IRB must approve the involvement of Lindenwood personnel, and Lindenwood must complete any required institutional or reliance process before Lindenwood personnel begin research activities.

The external study team may need to submit a modification adding the Lindenwood investigator and describing the investigator’s role.

Yes. Research involving children generally requires parental or guardian permission and the child’s affirmative assent, unless the IRB approves an appropriate waiver. The assent process must use language suitable for the child’s age, maturity, and ability to understand the study.

Only children whose required parental permission has been obtained should proceed to the assent process. Parental permission does not replace the child’s assent when assent is required, and a child should not be enrolled when they affirmatively decline participation.

Research involving minors may require expedited or full-board review depending on the procedures, risks, setting, and regulatory category.

It may. Employees may believe that participation could affect their employment, performance evaluation, assignments, advancement, or relationship with a supervisor.

The IRB may require safeguards such as third-party recruitment and consent, delaying a supervisor’s access to participation information, avoiding direct recruitment by the supervisor, and clearly explaining that participation will not affect employment.

No.

Anonymous data contain no information that identifies participants, and the researcher cannot reasonably connect the responses to specific individuals.

Confidential data may include identifying information or a code that can be linked to participants, but the research team limits who may access the information and protects it from unauthorized disclosure.

Do not enter identifiable, confidential, sensitive, proprietary, FERPA-protected, HIPAA-regulated, or otherwise restricted research data into a public or unapproved artificial intelligence platform.

Any proposed AI use should be described in the application, including:

• The tool and version;
• What information will be entered;
• Whether the provider retains or uses submitted information;
• Where the information is processed or stored;
• Whether identifiers will be removed;
• How outputs will be verified; and
• Whether institutional approval or a contract is required.

Researchers remain responsible for participant privacy, data security, accuracy, and compliance regardless of the tool used.

Not without prior IRB approval, unless an immediate change is necessary to eliminate an apparent and urgent hazard to participants.

Submit a modification in Cayuse before changing recruitment methods, eligibility criteria, study personnel, consent materials, procedures, instruments, compensation, study sites, data-security plans, or other approved elements.

When an urgent change is made to protect participants, notify the IRB promptly and submit the required report.

Usually, yes. Changes to data-collection instruments may affect risk, privacy, participant burden, eligibility, or the scope of the approved research. Submit the revised instrument through a modification before using it.

Minor administrative corrections that do not affect the research may be handled differently, but researchers should contact the IRB when unsure.

Promptly report events that may affect participant rights, safety, welfare, or privacy. Examples include:

• A breach of confidentiality;
• Lost or improperly accessed research data;
• An unexpected injury or significant distress;
• A complaint from a participant;
• Conducting an unapproved procedure;
• Enrolling an ineligible participant;
• Using an outdated or unapproved consent form; or
• Discovering that research began before approval.

Do not wait until the study closes to report a possible problem. Contact [email protected] for guidance and submit the appropriate report in Cayuse.

Research activities covered by the approval may need to stop, except when continued involvement is necessary to protect currently enrolled participants. Researchers may not recruit or enroll new participants under an expired approval.

Contact the IRB immediately for instructions. Researchers are responsible for tracking approval periods and submitting any required renewal or continuing-review materials on time.

Submit a closure when:

• Participant recruitment and interaction are complete;
• Identifiable data collection is complete;
• No follow-up with participants remains;
• Data analysis involving identifiable or coded information is complete; and
• No additional research activities requiring IRB oversight are planned.

A study should not be closed merely because recruitment has ended if the team is still working with identifiable research data.

Record-retention requirements depend on federal regulations, funding terms, sponsor requirements, contracts, institutional policy, the type of data, and whether the study is subject to additional rules.

Researchers must maintain required IRB records, consent documentation, permissions, data, and study files securely for the applicable retention period. The application should explain how records will be stored, protected, retained, and destroyed.

Yes. Researchers are encouraged to contact the IRB during the planning stage, particularly for projects involving minors, vulnerable populations, sensitive topics, interventions, physiological measures, external collaborators, institutional records, multiple study sites, or reliance arrangements.

Early consultation can help researchers select the appropriate application, consent template, recruitment process, and data-protection plan.

For IRB and application questions, contact:

Office for Research and Creative Activity
Email: [email protected]

For technical problems within Cayuse, contact the Cayuse Help Desk.

Common issues include:

• Procedures are incomplete or described differently across sections;
• It is unclear who will participate or what each participant group will do;
• Recruitment, screening, consent, and data collection are combined or confused;
• Consent forms do not match the application;
• Recruitment materials or instruments are missing;
• Risks are understated or safeguards are not explained;
• Data are described as anonymous when identifiers or linking codes exist;
• Data storage, access, retention, or destruction plans are incomplete;
• Compensation information is inconsistent;
• External permissions are missing;
• Study-team roles are unclear;

Researchers should review the complete application and all attachments as a single package before submitting.

The principal investigator is responsible for the overall conduct of the study. Each member of the research team is also responsible for following the approved protocol, protecting participants, maintaining required training, safeguarding research information, reporting problems, and obtaining approval before making changes.

Faculty advisors share responsibility for appropriately supervising student research.