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Research

Tips on Informed Consent

The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116 and ISU policy. The documentation of informed consent must comply with 45 CFR 46.117. The following resources are provided to assist with the development of the consent process.

A compilation of the consent requirements are provided in the checklist.

Tips on Informed Consent

Below are general tips on how to design informed consent. The order of the tips, follow the headings of the consent template.

General Content

  • Use simple language understandable to the participants. Avoid technical terms or scientific jargon. An eighth grade reading level is recommended for a general adult population.
  • Keep the form short. Use the checklist or templates as examples of what information is needed and avoid repeating information.
  • Consider what a reasonable person may want to know if they were trying to decide whether to participate and include that information.
  • Write the form in a neutral manner. Do not include text thanking them for their participation or that the researchers would be grateful if they participated. The form may still list the anticipated benefits of the research and indicate eligibility for compensation.
  • The form should be written in an informative manner instead of a legal document. Avoid the use of legalese text (e.g., "I understand that ...") that could be appear that the subject is waiving their rights.
  • If your study design requires that either you alter required consent content or do not obtain consent at all, you will need to request either an alteration or waiver of consent in the submission. The alteration or waiver will need to be justified by the researcher.

Study Description

  • Provide information that they may want to know about the activities. This may include indicating whether something is recorded, if there will be other participants present, or if they will be asked to engage in physical activity.
  • Indicate that participation is voluntary and that the participant will not be penalized if they choose not to participate or withdraw from the study. This should be emphasized more if the researchers may be in a position of power over the participants. (45 CFR 46.116[a][8])
  • If the person is expected to engage in the activity regardless of whether or not they agree to participant (e.g. course activity or work-related task), indicate what activities they are expected to do and clarify whether or not they will be asked to do anything extra if they agree to participate in the study.
  • If applicable, any alternatives to participating in the research project that may provide the same benefits should be described. For example, if you are studying an educational practice and those who chose to not participate in the study will engage in an alternate activity, describe the alternative activity.

Risks

  • The consent form should not state that no risks are anticipated. Instead, if you believe that this study does not pose any specific risk, indicate the following: "We do not anticipate any risks beyond those that would occur in everyday life."
  • If the data you collect would make it possible for the researcher to identify the participants and the data is sensitive (i.e. a data breach could harm the participant), this risk should be indicated. Sample language: "While it is possible that your reputation or employability may be harmed if a data breach occurs, we will take the following precautions to keep your information secure."
  • If it is anticipated that a physical injury could occur during the study, the participant should be told whether voluntary compensation and treatment will be provided.
  • Information on how any research-related risks can be mitigated should be described. This includes providing references to services that a participant could seek out if they are put at risk.

Data Security

  • Be clear in regards to whether the data is anonymous or confidential. If the researchers can identify the participants, it should not be indicated that responses are anonymous. If identifiers are collected, clarify the extent to which their data will be kept confidential.
  • If you are collecting data that would require mandated reporting, the following template language should be used: "We need to make you aware that in certain research studies, it is our legal and ethical responsibility to report [Select any that may apply: situations of child abuse, child neglect, or any life-threatening situation and/or illegal activity on the ISU campus, campus-controlled locations, or involving ISU students] to appropriate authorities. However, we are not seeking this type of information in our study nor will you be asked questions about these issues."

Compensation

  • Clearly indicate what the participant will need to do to be eligible for compensation
  • Use the Research Incentive Wizard to identify the specific comptroller language that is required
  • Do not list compensation as a benefit

Benefits

  • Describe the benefits that subjects may reasonably expect to encounter. There may be none other than a sense of helping the public at large.

Contact information

  • The participant must be told who to contact if they have questions about the research. This must be a research team member.
  • The participant must be provided information about who to contact if they have concerns. This must be the REC office. Suggested language: "If you have any questions about your rights as a participant, or if you feel you have been placed a risk, contact the Illinois State University Research Ethics & Compliance Office at (309) 438-5527 or IRB@IllinoisState.edu."

Documentation of Consent

  • A waiver of documentation should be used when obtaining a physical signature is not feasible for the study. If a signature line is not used then the consent form should still include a prompt to verify their consent. This is commonly used for electronic surveys and remote interviews.
  • An extra signature line or check box should only be used when the participant can pick which parts of the study to be engaged in. This can include situations when the being video recorded is optional.
  • Unless needed, documentation of those who do not agree to participate should not be obtained.