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Depending on your responses in the Basic Information section, additional sections may appear in your Cayuse HE application.

Your application should clearly describe who will participate in the research and how you will determine who is eligible to participate. The study population and eligibility criteria should be appropriate for the purpose of the research and consistent throughout your application and study materials.

When describing your study population:

• Clearly identify the population(s) you plan to recruit or enroll, including the anticipated age range and number of participants.
• If your study includes more than one participant group, clearly distinguish the groups and describe any differences in their eligibility or involvement in the research.
• Make sure your inclusion and exclusion criteria are specific and measurable so it is clear who is eligible to participate.
• Include only eligibility criteria that are relevant to the purpose, design, or safety of the study.
• Consider whether your research involves populations that may require additional protections or considerations (i.e., ).
• Make sure the population, age ranges, enrollment numbers, and eligibility criteria are consistent with your recruitment materials, consent documents, and study procedures.

Your application should clearly describe how potential participants will be identified, approached, and invited to participate. Recruitment should be appropriate for the study population and designed to support voluntary participation without undue influence or pressure.

When developing your recruitment plan:

• Explain how potential participants will be identified, who will approach or contact them, and how recruitment will occur, such as through email, flyers, social media, classroom announcements, online postings, or direct contact.
• Consider whether you or a member of the study team has an existing relationship or position of authority over potential participants, such as an instructor/student or supervisor/employee relationship, and how you will minimize the potential for undue influence or pressure to participate.
• Describe any screening or pre-screening activities used to determine eligibility, including what information will be collected and how screening will occur.
• Use clear, understandable language in recruitment materials and accurately represent the research without overstating potential benefits or minimizing risks.
• Include relevant information about the study, such as eligibility criteria, what participation involves, time commitment, compensation, and how interested individuals can learn more or express interest in participating.
• Make sure your recruitment materials are consistent with the information provided throughout your IRB application.
• Include all recruitment materials that potential participants will see or receive with your IRB submission, including flyers, emails, advertisements, social media posts, recruitment scripts, and other communications

Recruitment may not begin until the required IRB review has been completed and approval has been issued.

Resources: Recruitment templates and guidance are available on the Forms & Templates page.

Informed consent is an ongoing process that helps prospective participants understand the research and make an informed, voluntary decision about whether to participate. For most studies involving direct interaction with participants, the appropriate consent materials should be included with your IRB application.

Depending on the study design, the IRB may approve a waiver or alteration of informed consent. For example, a waiver of consent is commonly requested for certain retrospective records review studies where participants will not be contacted.

When developing your consent process and materials:

• Use clear, understandable language appropriate for your intended participant population and avoid unnecessary technical or scientific terminology. Consider using the Readability Assessment Tools available on the Forms and Templates webpage to help evaluate your materials.
• Clearly explain the purpose of the research, what participants will be asked to do, how long participation will take, and any reasonably foreseeable risks or potential benefits.
• Consider how and when consent will be obtained, who will obtain it, and whether participants will have sufficient time and opportunity to ask questions and decide whether to participate without coercion or undue influence.
• Your consent materials should accurately reflect the study procedures, risks, compensation, confidentiality protections, and other information described throughout your IRB application.
• Depending on your study, you may need parental permission, child assent, documentation of consent, or a waiver or alteration of informed consent.

Research Involving Children

When children are enrolled in research, parental permission and child assent may be required, depending on the research and the age and capacity of the children involved. Parental permission allows a parent or guardian to provide permission for their child to participate, while assent involves obtaining the child's affirmative agreement to participate when appropriate.

FERPA Consideration: If your research involves access to student education records, additional requirements may apply under the Family Educational Rights and Privacy Act (). Schools must have written permission from the parent or eligible student before releasing information from a student's education record.

Resources: Consent templates and guidance are available on the Forms & Templates page.

Your application should clearly describe what participants will experience from the beginning to the end of their involvement in the study and what information will be collected or used for research purposes. Provide enough detail for the IRB to understand how each research activity will be conducted.

When describing your study procedures and data collection:

• Describe study activities in a clear, logical, and chronological order, beginning with enrollment and continuing through completion of participation.
• Explain what participants will be asked to do, including surveys, interviews, focus groups, observations, interventions, assessments, or other research activities.
• Identify what data or information will be collected, how it will be collected, and the purpose of collecting it.
• Clearly describe the frequency and duration of study activities and the total anticipated time commitment for participants.
• Identify whether any activities will be audio recorded, video recorded, photographed, or otherwise electronically captured.
• If using existing records, datasets, or specimens, explain what information will be accessed and how it will be obtained for the research.
• Clearly distinguish between research procedures and activities that would occur regardless of the research, when applicable.
• Make sure the procedures described in your application are consistent with your consent materials, recruitment materials, surveys, interview guides, and other study documents.

Compensation or incentives may be offered to participants for their time and participation in research. Compensation may include monetary payments, gift cards, class credit, drawings or lotteries, SONA credit, or other incentives.

When planning participant compensation:

• Clearly describe the type and amount of compensation, when it will be provided, and how payments or incentives will be tracked.
• If participants complete multiple study activities or visits, explain whether compensation will be prorated if they withdraw or do not complete the entire study.
• The amount and method of compensation should be reasonable for the time and activities involved and should not create undue influence on a participant's decision to participate.
• Clearly describe compensation in the informed consent materials, including any requirements participants must meet to receive full or partial compensation.
• If offering class credit, consider whether students who choose not to participate in research will have an appropriate alternative method for earning comparable credit.
• If using a drawing or lottery, clearly explain how participants become eligible, the value and number of prizes, and how winners will be selected. · If payment will be made by check, gift card, or cash, contact SMU Purchasing regarding applicable payment requirements. The use of cash or checks as a payment method is strongly discouraged.
• Additional requirements apply when an individual participant may receive $2,000 or more in study payments during a calendar year, including collection of information needed for tax reporting.

Make sure the compensation described in your Cayuse application is consistent with the amount and payment schedule stated in your consent and recruitment materials.

Protecting participants’ privacy and maintaining the confidentiality of research data are important considerations throughout the research process. Your application should clearly explain how these protections will be maintained during recruitment, data collection, storage, analysis, and reporting.

When developing your study:

• Privacy refers to the circumstances under which participants are approached, interact with the research team, or provide information. Consider whether recruitment, consent, interviews, surveys, or other study activities will occur in a setting that appropriately protects participants’ privacy.
• Confidentiality refers to how information collected about participants will be protected from unauthorized access, use, or disclosure.
• Collect only the identifiable information necessary to accomplish the research objectives.
• Clearly describe whether data will be anonymous, coded, de-identified, or identifiable, and whether a code key or other method could be used to link the data back to participants.
• Explain where and how research data will be stored, who will have access, and what safeguards will be used to protect identifiable or sensitive information.
• If identifiers will be removed or destroyed, describe when and how this will occur.
• Consider whether collecting or storing particularly sensitive information requires additional protections.
• Describe how confidentiality will be maintained when research findings are presented, published, or otherwise shared.

Your application should describe how research data will be collected, stored, accessed, shared, and ultimately retained or destroyed. Data security protections should be appropriate for the type and sensitivity of information collected and should be maintained throughout the research project.

When planning how you will manage your research data:

• Identify what types of data will be collected, including whether the data will contain direct identifiers, coded information, or sensitive information.
• Describe where research data will be stored and the systems or platforms that will be used for data collection and storage.
• Limit access to research data to authorized study team members who need the information to perform their research responsibilities.
• Use appropriate security measures to protect identifiable or sensitive information from unauthorized access, loss, or disclosure.
• If data will be transferred or shared with collaborators, describe how the data will be securely transferred and what information will be shared.
• If a code or study ID is used, store the code key separately from the research data whenever possible.
• Describe how long research records will be retained and whether identifiable information will eventually be de-identified or destroyed.
• Make sure the data management practices described in your application are consistent with your consent materials and actual study procedures.

For guidance on secure data storage and management, see SMU Resources for Data Management.

Your application should identify the reasonably foreseeable risks or discomforts participants may experience as a result of the research and explain how those risks will be minimized. Risks should be considered in relation to the specific study population and research activities.

When evaluating the risks and potential benefits of your study:

• Consider risks beyond physical harm, including psychological or emotional discomfort, social risks, legal risks, financial risks, and risks related to loss of privacy or confidentiality.
• Describe the likelihood and severity of potential risks or discomforts rather than simply stating that the study presents “minimal risk”
• Explain the steps you will take to reduce or manage identified risks, including what the research team will do if a participant experiences distress or another adverse event.
• Consider whether any participant population may require additional protections because of the nature of the research or their circumstances.
• Clearly distinguish between direct benefits to participants and broader potential benefits to society, a field of study, or future populations.
• Do not describe compensation, course credit, or other incentives for participation as a benefit of the research.
• If participants are not expected to receive a direct benefit, state this clearly rather than suggesting that participation will personally benefit them.
• Make sure the risks and benefits described in your application are consistent with your informed consent materials.

Avoid simply writing that there are “no risks.” Even low-risk studies may involve inconveniences or potential harms, such as discomfort answering sensitive questions or a breach of confidentiality. Identify the risks that are reasonably foreseeable for your specific study and explain how you will minimize them.