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Informed Consent Checklist

When using humans as research subjects you must first obtain their informed consent.

Use this checklist to effectively create an informed consent form. Sample Informed Consent Letters can be found here.

  • A statement explaining the purpose of the research
  • A statement of the expected duration of the subject’s participation
  • A description of the procedures to be followed
  • A description of any reasonable foreseeable risks or discomforts to the subject, including invasion of privacy
  • A description of any benefits resulting from the research, either to the subject or to others
  • A statement that informs subject of his/her right not to be a subject in a research project that is also a teaching exercise
  • A statement informing subject about how his/her anonymity will be guarded; i.e., that their confidentiality will be protected by assigned code numbers, by limitations of who has access to data, by data storage in locked cabinets, by locked computer files, etc.
  • A statement that the subject’s participation is voluntary, and that his/her refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
  • If written informed consent is required, a place for the subject to sign and date the form and a statement that a copy of the signed consent form will be given to the subject for his/her records
  • If the subject is a minor, a statement of parental responsibility in consenting to the child’s participation in the study with a place for the parent to sign and date the form in addition to the participant’s signature
  • The name, address, and telephone number of the principal investigator of the research project, and his/her affiliation with Calvin College. If the principal investigator is a student, the name and telephone number of the faculty advisor is also required.
  • A statement informing the subject that inquiries regarding the nature of the research, his/her rights as a subject, or any other aspect of the research as it relates to his/her participation as a subject can be directed to Calvin’s Committee for the protection of Human Subjects in Research.

Submit a digital copy and one signed hard copy of your full and complete proposal to the IRB chairperson 3 weeks before the planned start of your study.

The current committee chair is Beth Byma, Assistant Professor of Nursing.