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Informed Consent

Informed consent is more than just a form; it is a process that takes place between researcher and subject, forming the basis of ethical research that respects the autonomy of research subjects. The "informed" in informed consent means the subject has all the information necessary to make a decision. 

The principle of informed consent applies to ALL types of research, including surveys, interviews, and observations in which subjects are identified, and other experiments, such as diet, drug, and exercise studies. Typically, a "consent form" documents that the informed consent process has taken place. Keep in mind that, while there are certain regulatory requirements pertaining to informed consent, there are also a wide variety of ways one might move through that process. Recent studies have shown, for example, that interactive informed consent processes or supplemental videos enhance subjects’ understanding of the research process. 

The consent form/script must be written in language easy for the participant to understand. Avoid technical terms and complex sentences, regardless of your intended audience. Informed Consent is more that just a form. It is an ongoing process that starts as early as recruitment, continues throughout the person’s participation in the research, and may extend until the completion of the research.

Does my Exempt Study Require Informed Consent?

Formal written informed consent is not required for research determined to be exempt from IRB review. However, the Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction with the participant. Because formal written consent is not required for studies confirmed as meeting the criteria for exempt review, it allows PI’s greater flexibility in the informed consent process.

The IRB recommends that researchers provide participants with, at a minimum, the information listed below during the consent process and before any data collection begins.

Minimum Consent Process Information for Exempt Studies:

  • A statement that the activities involve research;
  • A clear description of study procedures to be performed;
  • A statement that participation is voluntary;
  • A brief statement how investigator will maintain privacy and confidentiality;
  • A statement about how data will be used in the future; and
  • The name, affiliation and contact information of the researcher.

Note: Other regulations such as FERPA, HIPAA, or GDPR may require written consent regardless of the level of IRB review. In order to process deception/incomplete disclosure studies at the Exempt level, prospective agreement must be obtained.

Informed Consent Templates

Informed Consent Form templates frequently need to change for a variety of reasons. Investigators are required to use the newest versions of consent forms whenever you submit a new protocol (if you need to obtain consent). You do not have to use the newest templates when revising previously approved consent(s) unless the IRB specifically instructs you to do so.

Research HIPAA/Protected Health Information (PHI)

For research involving protected health information, the IRB requires that HIPAA authorization be included as part of the main informed consent document and not provided as a separate document (except for Dayton VA Medical Center studies or other justified exceptions). The IRB also requires that authorization template language be utilized word-for-word except for sections that are required to be customized on a study-by-study basis per template instructions.

Informed Consent Checklists

Informed Consent Guidance