Researchers are obligated to share information with potential study participants as part of the informed consent process. This is a core element in the protection of research participants and reflects fundamental principles of research ethics as stated in the Belmont Report: respect for persons, beneficence, and justice. Each of the following elements must be addressed per the proposed study’s interventions. IRB approval is contingent upon adequately addressing these elements in the informed consent process. The consent form templates provided on this site include these required elements. Once approved, only the versions that were included in the approved protocol should be used. Any substantive changes to approved consent documents require further IRB review.
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subjects.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- For research involving minimal risk, an explanation as to whether any medical treatments or compensation are available if injury occurs and, if so, what they consist of or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that participation is voluntary and refusal to participate will not involve penalty or loss of benefits to which the subject is otherwise entitled, that the subject may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled, and that the subject will receive a copy of the signed informed consent.
Research not requiring written consent
Research involving no more than minimal risk of harm to human participants still requires the participants’ informed consent, but may not require that participants sign a written consent form. Anonymous surveys, for example, do not require written consent. Subjects who do not consent simply do not fill out the survey. Nonetheless, there are several requirements to ensure that participation is voluntary. Surveys and interviews must be conducted in a setting and manner that is non-coercive. The researcher should provide the participants with the following information, which may be listed in a disclosure form:
- An explanation of the nature of the research so that participants know they will be involved in a research study;
- The names of those who are conducting the survey and any sponsoring organizations;
- The uses that will be made of the research information;
- A description of who is being surveyed or interviewed;
- Assurance that responding to the survey or interview questions is voluntary and that even if participants decide to participate they may refuse to answer questions or terminate the interview; and
- An explanation of whether those conducting the survey will know the participant’s identity.
Waiver of written consent
The IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
- When the only record linking the participant to the research would be the written consent form and breach of confidentiality is the principal risk, provided the participants are asked whether they want to sign a written consent form and allowed to do so if they desire; and
- When there is no more than minimal risk and written consent is usually not required outside the research context.
- The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
No Waiver of Liability Language
Whether the participant’s consent is written or verbal, it should not include exculpatory language through which the participant is made to waive any of his or her legal rights or release the researchers, research sponsor, or Macalester College from liability.