Student-Led Research Projects

Course-Based Research Experiences (CBREs), sometimes referred to as research practica, are research activities completed as part of a regularly scheduled academic course under the supervision of your instructor. These activities are primarily designed to help you learn about the research process and develop research skills.

Depending on the course, you may gain experience with activities such as:

• Conducting interviews or observations
• Administering surveys
• Collecting or analyzing data
• Developing research questions or study procedures
• Writing or presenting research findings

Activities CBREs are generally conducted solely for instructional purposes rather than to contribute to generalizable knowledge. Because of this, many CBRE activities do not require formal IRB review.

Examples may include class assignments designed to teach research methods, projects completed solely for a course grade, or findings shared only within the course or academic program.

Your Responsibilities

If you are completing a CBRE, you should:

• Follow the research activities and procedures established by your instructor.
• Complete any training required for the course.
• Keep your activities within the scope of the course assignment.
• Discuss any plans to present, publish, or use the project outside the course with your instructor before doing so.

If your instructor ask you to complete a CBRE application in Cayuse Human Ethics, select “Yes” to Course-Based Research Experience (CBRE) when you identify your SMU affiliation as “Student”.

When creating the study:

• Begin the study title with “CBRE - ” (e.g., CBRE – Study Title).
• List your instructor as your Faculty Advisor.
• Certify and submit the CBRE application to your instructor/Faculty Advisor review.

Note: A CBRE application is completed as an educational activity and is not intended to initiate formal IRB review.

For Instructors

Instructors are responsible for determining whether an activity is appropriate as a CBRE or whether it may constitute Human Subjects Research requiring IRB review.

If students are asked to complete a CBRE application in Cayuse, the instructor/Faculty Advisor should review the application but should NOT certify the study in a manner that initiates formal IRB review.

If you or your instructor are unsure how an activity should be handled, contact Research Integrity & Compliance (RIC) before beginning the project.

Not every student project involving data, information, or people meets the federal definition of Human Subjects Research.

Examples of projects that do not meet the federal definition of human subjects research and therefore do not require IRB approval may include:

• Literature reviews or systematic reviews that do not involve living individuals or identifiable private information.
• Research using publicly available or de-identified datasets that cannot be linked to individual identities.
• Certain quality improvement or program evaluation activities.
• Projects involving non-human data or specimens that are not linked to identifiable individuals.

If your project involves obtaining information or biospecimens from living individuals through intervention or interaction, or involves the use of identifiable private information or identifiable biospecimens for research purposes, your project may require IRB review before you begin any research activities.

Work with your Faculty Advisor early in the planning process to determine whether your project may require IRB review. If you are unsure or need formal documentation that IRB review is not required, Research Integrity & Compliance (RIC) can provide an official Not Human Subjects Research (NHSR) determination.

Need help determining whether your project requires IRB review? Visit Do I Need IRB Review? to learn about Human Subjects Research, common activities that may not require IRB review, and how to request an official NHSR determination.

Directed or Independent Research Projects includes student-led projects conducted outside of a standard classroom assignment or CBRE that meet the federal definition of Human Subjects Research.

Examples may include:

• Honors theses
• Master's theses
• Dissertations
• Capstone projects
• Independent studies
• Summer research projects

These projects are conducted under the supervision of an SMU Faculty Advisor and are typically designed to answer a research question or contribute to disciplinary or generalizable knowledge.

What You Need to Do

If you plan to conduct Human Subjects research, work with your Faculty Advisor early in the project planning and development process. Your Faculty Advisor will help guide the development of your study and provide oversight throughout the research process.

If IRB review is required, you must submit your study through Cayuse Human Ethics and receive the appropriate IRB approval or determination before beginning any human research activities, including recruitment. Because IRB review can take time, begin preparing your application well in advance of your anticipated project start date.

If you plan to conduct research involving human participants, discuss your ideas with your Faculty Advisor as early as possible. Together, you should consider whether your project may require IRB review and identify any additional requirements that could affect your research.

If you are unsure whether IRB review is required, visit Do I Need IRB Review? for guidance on determining whether your project may be considered Human Subjects Research and when an official determination may be needed.

Note: IRB approval cannot be granted retroactively. If you are unsure whether your project requires IRB review, find out before beginning research activities, including recruitment.

If your project requires IRB review, begin the process early. Remember: IRB approval cannot be granted retroactively. If you are unsure whether your project requires IRB review, find out before beginning research activities, including recruitment.

As you prepare your project:

• Develop your study materials early. This may include recruitment materials, consent documents, surveys, interview or focus group guides, and other data collection instruments. Complete required training. You, your Faculty Advisor, and other applicable study team members must complete the required CITI Human Subjects Research training before the study can receive IRB approval.
• Plan for external research sites. Research conducted at schools, community organizations, domestic or international locations, or other external sites may require additional permissions, agreements, or local review.
• Allow time for IRB review. Review timelines vary based on the type and complexity of the research and whether revisions are needed.

Note: Research activities involving human participants may not begin until any required IRB review has been completed and the appropriate determination or approval has been issued.

Throughout your project, stay in regular communication with your Faculty Advisor. Ask questions when you are unsure about a research activity or requirement, and discuss any proposed changes to your study before implementing them.

A few practices can help keep your research on track:

• Follow your approved study. Conduct your research according to the procedures and materials approved by the IRB.
• Ask before making changes. Changes to an approved study may require a Modification in Cayuse before they can be implemented.
• Report problems promptly. Discuss protocol deviations, unexpected events, participant concerns, or other study issues with your Faculty Advisor and RIC.
• Keep your study current. Complete any required ongoing submissions and maintain appropriate research records throughout the project.
• Close your study when finished. When all research activities are complete, submit a study closure in Cayuse when required and maintain your research records in accordance with applicable university and sponsor requirements.

You should become familiar with the resources available through Research Integrity & Compliance (RIC), including guidance documents, training resources, office hours, and consultation opportunities.

Incomplete or inconsistent applications are common reasons a submission may require revisions before IRB review can move forward. Before submitting, watch for:

• Missing Study Materials: Include all applicable materials, such as survey instruments, recruitment materials, consent forms, or interview guides.
• Inconsistent Information: Make sure the information in your Cayuse application matches the information as described in the study documents.
• Expired or Incomplete Training: Confirm that you, your Faculty Advisor, and applicable study team members have completed the required CITI training and that the training is current.
• Poor Document Quality: Submitting applications or consent forms that contain excessive technical jargon, grammatical errors, or unclear descriptions of study procedures.
• Incorrect Project Personnel: Make sure your Faculty Advisor and all applicable study team members are correctly listed in Cayuse.

Once your study is approved, you are responsible for following the research procedures and materials approved by the IRB. Common issues to avoid include:

• Failure to Obtain Informed Consent: Beginning research activities before obtaining consent when required, or using a consent document that has not been approved for the study.
• Protocol Deviations: Changing study procedures, recruitment methods, survey or interview questions, consent materials, or other approved activities without first obtaining IRB approval when required.
• Undue Influence in Recruitment: Recruiting participants in a way that may make them feel pressured or obligated to participate, particularly when you have a position of authority over potential participants (i.e., a teaching assistant recruiting from their own class without the use of a neutral third party).
• Enrolling Ineligible Participants: Enrolling individuals who do not meet the eligibility criteria approved for your study.

Protecting participant information is an important responsibility throughout your research. Make sure your data practices remain consistent with what was described and approved in your IRB application.

Common issues include:

• Confidentiality Breaches: Failing to adequately secure identifiable research data or allowing unauthorized individuals to access participant information.
• Confusion of Terms: Describing data as “anonymous” when in actuality identifiers are collected and retained, which may result in inadequate privacy and data security protections.
• Poor Data Management Practices: Storing, transferring, or sharing research data in a way that does not provide the protections described in your approved study.
• Research Integrity Concerns: Failing to accurately report study results, selectively reporting findings, or otherwise engaging in practices that compromise the integrity of the research.

For additional guidance on protecting participant information, refer to the Data Management Resources webpage.

It depends on the purpose and intended use of the project. Some classroom activities and other student projects may not meet the definition of Human Subjects Research, while theses, dissertations, independent research, and other projects involving human participants may require IRB review.

The table below provides common examples:

Do not wait until after you begin your project to determine whether IRB review is required. Discuss your project with your Faculty Advisor early in the planning process.

Visit Do I Need IRB Review? for guidance on Human Subjects Research, projects that may not require IRB review, and how to request an official determination.

Your Faculty Advisor must be an SMU faculty or staff member who has the appropriate knowledge and experience to provide guidance and oversight for your research.

Your Faculty Advisor should be able to commit sufficient time to review your study, guide you through the IRB process, and provide ongoing oversight throughout the project.

No. The IRB cannot grant approval retroactively for research that has already been initiated or completed.

If human subjects research is conducted without the required IRB approval, the IRB cannot issue an approval or exemption after the fact to validate those activities.

As a student researcher, you must conduct your study under the supervision of your Faculty Advisor and only perform research activities for which you are appropriately trained and qualified.

You should only conduct procedures that have been approved by the IRB. Students are prohibited from independently performing medical procedures, diagnosing illnesses, administering medications, or providing mental health services to study participants as part of the research project.

You should also avoid recruitment situations that could create pressure or undue influence, such as recruiting participants from a class where you have authority or evaluative responsibilities.

Informed consent is an ongoing process that helps prospective participants understand the nature of the research and make an informed, voluntary decision about whether to participate.

In general, informed consent should include:

• A clear explanation of the study's purpose and procedures
• How long participation will take
• Reasonably foreseeable risks and potential benefits
• Information that participation is voluntary
• Notice that participants may withdraw at any time without penalty
• Information presented in plain, non-technical language appropriate for the intended audience

• Anonymity: No identifying information is ever collected and participants cannot be linked to their responses.
• Confidentiality: Identifying information is collected but kept private and removed from final reports.

Study records should be maintained securely for at least three years after the completion of the research, unless a sponsor, funding agency, or other requirement specifies a longer retention period.

If you are graduating or leaving SMU, work with your Faculty Advisor before you leave to ensure that research records are appropriately retained or transferred and that any required study closure is completed in Cayuse.

If you are unable to complete the closure process, your Faculty Advisor will need to assume responsibility for the study and ensure that the appropriate IRB requirements are completed.