Forms and Templates

Informed Consent Forms

According to the Department of Health and Human Services Office for Human Research Protections, all informed consent forms must contain:

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 that are experimental;
A description of any reasonably foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others that 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;
An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

Additional details, such as information on the storage of biospecimens, potential costs for participation, unforeseeable risks, and/or presentation of the study findings should also be included as appropriate. A full listing of the required and recommended elements of informed consent forms can be found here: 45 CFR 46.116 - Informed Consent Details

We have created two Informed Consent templates to help you with creating one for your study.

Non-Medical Consent template: this Informed Consent mostly includes examples for correlational and experimental studies that do not involve medical interventions. It is geared more toward social and behavioral research that has only minimal risk associated with it.

Medical Consent template: this Informed Consent form is more geared toward medical research, such as clinical trials or other interventions.

Protected Populations

Research involving protected populations, including pregnant people, children, and people in prison, requires additional steps and considerations in order to ensure that the research is being conducted according to ethical standards.

When children or other individuals of diminished cognitive capacity are included as participants, researchers may need to obtain participant assent in addition to obtaining informing consent from a legal guardian or other representative. In the case of individuals of diminished cognitive capacity, researchers may need to determine cognitive age in order to decide what level of consent or assent is appropriate.

Cognitive age younger than age 7: Individuals with a mental age younger than age 7 are generally not considered capable of providing assent, since their age affords limited ability to understand research procedures, risks, and benefits, and to make an informed decision. Researchers should obtain consent from the parent or legal guardian but are not required to obtain assent from the participant.
Cognitive ages 7-13: Research personnel should have a conversation in age-appropriate language with individuals, and they should affirmatively assent to participate. If the study team believes that a written assent document will provide value to the assent process, it must be written using language that can be understood by the potential subject with the youngest mental age (above 7 years old) and approved by the IRB. Consider using non-text elements like pictures or icons to describe your study as needed.

Research Assent Form template

Cognitive ages 14-17: Since informed consent documents are to be written in 8th-grade language, individuals with a mental age between the ages of 14 and 17 should be able to understand the content in the IRB-approved informed consent document. Study teams are encouraged to use the informed consent document to obtain assent from individuals in this cognitive age group, including them in the informed consent conversation with the parent/guardian, and having them indicate assent by signing the informed consent document.

Minor Full Consent

Atypical Consent Processes

Occasionally, researchers may need to obtain approval to use an Implied Consent procedure (also known as passive consent) or even an informed consent waiver. These might be necessary in cases when there is no more than minimal risk AND an active informed consent process would be prohibitive. For example, a consent waiver might be granted for an observational study in which the researcher gathers personal identifying information but does not directly interact with the participants. Implied/passive consent might be approved for an in-school survey that is low risk but that could not be completed because the participants would be unlikely to remember to return the signed consent forms (though in this case, active assent from participants may still be required).

Informed Consent Waiver request form

Implied Consent request form

Medical Research

Conducting research related to medical conditions often requires researchers to obtain some of the participants' protected medical information (PHI). Although analysis of medical records is considered secondary data analysis and is therefore exempt from needing IRB approval (45 CFR 46.104), medical records are protected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In order to obtain a participants' medical records, researchers will need to obtain a signed HIPAA Authorization form from the participant or else to be granted a HIPAA Authorization waiver from the Institutional Review Board.

HIPAA Authorization form

IRB HIPAA Authorization Waiver request

Researchers may also conduct secondary analysis of PHI without an authorization form or waiver if the records they obtain have been "de-identified", meaning that all personal identifying information has been removed from the records prior to the researcher receiving the documents. When submitting their IRB proposal, researchers should include a signed form certifying that all data have been deidentified.

HIPAA De-Identification Certification form