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Cape Cod Community College Institutional Review Board (IRB) Guidance for Student Research and Class Projects involving Human Subjects

Cape Cod Community College (CCCC) is committed to maintaining the highest ethical standards in research involving human subjects. The Institutional Review Board (IRB) ensures that participants' rights, welfare, and privacy are protected in accordance with federal regulations.

Any student research or class project that involves human subjects and meets one or more of the following criteria will require IRB approval.

• Any project where data will be published or shared with a research community or the public at large (e.g., Honors Program receptions, conference presentations).

• Projects involving protected populations (e.g., minors, prisoners, pregnant women, or individuals with limited capacity to provide consent).

• Projects involving sensitive information, such as mental health, sexual behavior, illegal activities, or data that could potentially harm participants if disclosed.

 

IRB Approval Process

(1) Complete required training

All students and instructors participating in human subjects research must complete training on the ethical principles guiding such research.

• Faculty Advisors are required to complete Lesson 1 (When HHS Regulations Apply) and Lesson 2 (What is Human Subjects Research?) from the online Office for Human Research Protections (OHRP) Self-Assessment Training, available at Human Research Protection Foundational Training, and submit the certificates of completion to: IRB@sukamembaca.net. Certification must be renewed every three years.

• Students are required to watch an education video about human subjects research and complete a quiz available through the Institutional Review Board shell on Moodle. Faculty Advisors should coordinate with the Office of Institutional Research and Planning to set up this training module for their student researchers.

 

(2) Create an Informed Consent Form

• Informed consent is essential for all projects involving human subjects. The consent form must clearly explain the project’s purpose, procedures, and any risks or benefits. It should also state that participation is voluntary, and confidentiality will be strictly maintained, and participants must be as least 18 years of age. In developing a consent form for a specific research project, please note the following points:

  • Purpose and Procedures: A clear description of the research purpose and the activities participants will be expected to undertake.
  • Risks and Discomforts: A description of any potential risks or discomforts participants may experience.
  •  Benefits: Any expected benefits to the participant or to others.
  • Confidentiality: Information on how the participant's data will be stored, protected, and shared.
  • Voluntary Participation: A statement that participation is voluntary and that participants can withdraw at any time without penalty.
  • Contact Information: How participants can contact the researchers or the IRB with questions or concerns.
  • Consent Statement: The participant’s acknowledgment of their understanding and agreement to participate by signature.

Please consider using the following Informed Consent Template to ensure that your consent form includes all necessary information.

(3) Complete the IRB Application

Please submit the IRB Research Application, which has been signed by both the Faculty Advisor and Student, and project materials (e.g., recruitment script, surveys, informed consent, etc.) to: IRB@sukamembaca.net at least three weeks prior to the research start date to ensure timely review. Please ensure you receive IRB approval before starting your research project.

Faculty Advisor Responsibilities

Instructors play a key role in ensuring that student projects adhere to ethical standards, even if IRB approval is not required. Faculty Advisors should:

  • Review student proposals to determine if the project qualifies as research.
  • Ensure that projects involving protected populations or sensitive information are submitted for IRB review.
  • Guide students in developing informed consent procedures, maintaining data confidentiality, and ensuring that no personal identifiers are collected or retained unnecessarily.
  • Make sure that they have current certificates of completion on file with the IRB for their human subjects research training modules.
  • Make sure students complete the required training in ethical research practices.
  • Review the IRB Application with the students to ensure that it is complete prior to submittal to the IRB.

Instructors and departments are encouraged to contact the IRB for guidance on topics such as privacy, confidentiality, informed consent, and professional ethics when planning class projects as part of a course syllabus.

Still have Questions?

For any questions about whether a project requires IRB review, or for guidance on ethical research practices, contact: IRB@sukamembaca.net as early as possible in the project planning process.