New protocol submissions to COUHES after January 21, 2019 are subject to the Revised Common Rule, also known as the New Rule, and must fulfill the requirements outlined under the New Rule.
Introduction to Informed Consent
Informed consent is designed to ensure study subjects understand what they are being asked to do and that they are voluntarily agreeing to do it. As such, it should provide all subjects with clear information on the purpose, procedures, requirements, potential risks and other relevant information associated with participation in a study.
Except as provided below, Federal regulations and MIT Policy require that informed consent be obtained from all participants in studies that involve human subjects.
In general informed consent should be documented by the use of a written consent form signed by the subject or the subject’s legally authorized representative.
This website provides:
- Templates of the informed consent forms you may use in preparing your application
- Guidelines for providing and communicating adequate information and ensuring comprehension
- Additional Standard Language for canned phrases and language that can be added when appropriate to the research.
- Outline of the Basic Elements of Informed Consent required for all human subject research unless waived by COUHES.
- Guidelines for obtaining electronic consent.
Waiver or Alteration of Informed Consent Request
At the discretion of COUHES, the requirement for a signed informed consent may be waived. Situations where this may occur include the following:
- That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If 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.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
Additionally, COUHES may waive the requirement to obtain informed consent, or may waive some of the elements of informed consent. Situations where such a waiver may be granted include the following:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- 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;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
If you are requesting a waiver or alternation of informed consent or a waiver of documentation of consent, please attach the Waiver or Alteration of Informed Consent Request to your COUHES application upon submission.
In studies where minors or other vulnerable populations are involved as subjects, a parent or guardian may be required to sign an informed consent form and the minor sign an assent form (see Guidelines for Selected Populations).
Informed consent involves more than obtaining a signature on a form. It requires educating prospective subjects and ensuring they clearly understand what they will be asked to do, for how long, and describing potential consequences or risks (if any), that may be associated with a study.
Serious problems have occurred when participants sign informed consent forms but later realize that they did not fully understand the commitments. To avoid this type of problem, you need to make sure that the informed consent process has adequate information, communication, and comprehension.
- The types of information required in informed consent forms are shown in the templates.
- The amount of detail to provide may vary based on the procedures and potential risks in each study.
- The way information is provided is important in ensuring comprehension.
- Tasks should be explained from the subject's point of view.
- Use the pronoun "you" consistently throughout the document.
- Descriptions should be concise.
- Language should be simple and clear.
- Wording should be understandable to those with an 8th grade reading level.
- Avoid technical language or jargon.
- Use commonly recognizable terms.
- Explain terms that may not be easily understood.
- When minors are involved, use age-appropriate language.
- Participants should have time to think about their decision or to discuss their involvement with family, friends, or advisors.
- Tasks should be explained from the subject's point of view.
- Information on the study may be communicated initially in writing. It should also be discussed in conversation, with adequate time for and encouragement of subject questions.
- Investigators must also ensure that prospective subjects have gained an accurate understanding of study requirements, procedures, and potential risks.
- A suggested sequence for accomplishing this is to:
- Provide informational materials and the informed consent form to the prospective subject.
- Read through key segments with the subject, and explain significant or complex points. Answer any questions.
- Allow the participant time to take the materials home and discuss participation, if desired, with family or friends.
- Ask open-ended questions to make sure the subject understands the study and the nature/requirements of participation.
- If, after this process, the prospective subject remains willing, ask him or her to sign the informed consent document.