You're required to have all participants in your study complete an Informed Consent Form. See an example of an Informed Consent Form (pdf).
Below are the Bethel University Institutional Review Board’s elements of informed consent for research with humans. Please also consult the Federal Regulations.
- Statement that the study involves research, an explanation of the purposes of the research, and reason for participants’ selection.
- The approximate number of participants involved in the study.
- A description of the procedures to be followed, and identification of any procedures which are experimental.
- Length and frequency of procedures, including an estimate of the total amount of participants’ time.
- A description of any reasonably foreseeable risks, discomforts, or costs to the participant and options available to the participants for managing the risks, discomforts, or costs.
- A description of any benefits to the participant or to others, which may reasonably be expected from the research.
- With respect to confidentiality, if data obtained will be made available to any person or organization other than the participant, the investigator, and the investigator’s staff, the person(s) or agencies to whom information will be furnished, the purpose of the disclosure, and the nature of the information to be furnished must be described. Reporting of data must be done in such a way that individuals will not be identifiable. If tape recordings, photographs, movies or videotapes are used, they should be described. The time they will be retained before they are destroyed should be specified. Use of such data for other purposes must be disclosed and permission obtained in a special portion of the consent form.
- A statement that participation is voluntary, the person may refuse to participate, and may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled, and instructions for discontinuing participation in an orderly manner.
- A statement that significant new findings developed during the course of the research which may relate to the person’s willingness to continue participation will be provided to the participant.
- Anticipated circumstances under which a person’s participation may be terminated by the investigator without regard to the participant’s consent.
- An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related problem. Include telephone number.
- An offer to the participant of a copy of the consent form.
- Oral or written assent of minors depending on age and maturity.
- Space for the signature and date. If applicable, there should be space for signature by parent or guardian, along with a space for the signer to indicate his/her relationship to the participant. The signature of the investigator is recommended in order that it can be established who discussed the study with the participant. If applicable, there should be space for the signature of a witness.