Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before subjects may be included in research.
The primary purpose of informed consent is to protect the prospective human subjects. Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research.
Keep in mind that obtaining informed consent is a continuous process throughout the research, not simply a one-time event when a subject signs a form.
To ensure informed consent, researchers should:
Work to communicate clearly and effectively with their participants and to build trust and cooperation.
Openly and willingly explain their research, answer questions and be sensitive to the needs and concerns of their prospective research participants.
Informed consent forms and scripts should be written at an eighth-grade reading level to ensure that prospective subjects are truly informed. See the Informed Consent Template for an example of informed consent at the eighth grade reading level. (For additional help, see Readability Tools below.)
When using an informed consent form, a final version, as it will appear to your subjects (e.g., on letterhead), must be included in the protocol.
If no informed consent form will be used, a waiver for documented informed consent must be requested and an information sheet and/or informed consent script may be required.
Obtaining informed consent is most often accomplished through an informed consent form, which documents the information regarding the research the subject is being given to help him/her make the decision to participate or not in the research.
While each informed consent form is specific to its research project, the federal regulations dictate the elements of informed consent that must be included. See information regarding guidelines and a template (pdf) for creating an informed consent form.
Note that, for complicated and/or lengthy (greater than three pages, generally speaking) informed consent forms such as those often used for clinical research, the forms must begin with an organized, concise, and focused presentation of the key information contained in the consent documents.
Note, as well, that all subjects must be provided with a physical copy of the informed consent form. (If electronic informed consent is being obtained, an electronic version of the informed consent form is adequate.)
When the use of an informed consent form would be impractical or detrimental to the study, a waiver may be requested. Federal regulations allow an IRB to waive the requirement to obtain written documentation of informed consent for some or all subjects under any of the following circumstances:
When the consent document would provide the only link to the subject and the principal risk of the research would be a breach of confidentiality. Note that each subject (or LAR) must be asked whether they would prefer to sign a consent form, linking them with the research. The subject's wishes must govern.
When the risk to the subjects is minimal and consent would not be required outside the research context.
- When the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.
If you would like to request a waiver of documented informed consent, explain in your protocol how any of the above circumstances apply to your research. Be sure to clearly explain why you believe your research qualifies for the waiver.
Where the IRB waives the requirement for documented informed consent, investigators must understand that they are still required to communicate all the required elements of informed consent to their subjects and that the subject's active consent must be obtained before proceeding with the research.
Examples of projects that might qualify for a waiver of documented informed consent include online anonymous surveys, telephone surveys, and interviews with a vulnerable population (e.g., domestic violence survivors or undocumented immigrants).
Note that if documented informed consent is being waived, the IRB may require an information sheet be given to the subjects and/or an informed consent script be included in your protocol.
Note, as well, that if feasible, the fact that informed consent was obtained should be documented (e.g., a checkmark on a master list).
In cases where documentation of consent is waived, the IRB may require investigators to provide subjects with a written statement regarding the research called an Information Sheet.
The information sheet generally includes all the elements of informed consent and looks similar to an informed consent form, without requiring the subject's signature.
Keeping in mind that informed consent is more than a form, an informed consent script may be required.
An informed consent script outlines how the investigator will conduct the informed consent process and what s/he will say to the subjects to explain this process.
An informed consent script may be necessary when a waiver of documented informed consent is being requested and an information sheet is not feasible.
In rare instances the Institutional Review Board may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent entirely provided it finds:
The research could not practicably be carried out without the waiver.
The research involves no more than minimal risk to the subjects.
The waiver will not adversely affect the rights and welfare of the subjects.
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
E-signatures are permissible provided the subject's identity is verifiable. If the subject’s identity is not verifiable, a request for a waiver of documented informed consent must be requested.
Note that the Massachusetts Uniform Electronic Transactions Act requires four elements to create a valid electronic signature and fulfills both OHRP and FDA requirements:
Capturing the user's intent.
Binding of the signature to the document.
Maintaining the integrity of the document.
In addition, the electronic signature must also capture and record the date that the subject provides consent.
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- Readability Calculator *
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* Note that the HRPP uses the Flesch Kincaid grade level to judge readability