What Type of Informed Consent is Required for Research?

This should be viewed in conjunction with the flowchart 

Reference: 45 CFR 46.116
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

Legend:
PI = Principal Investigator
ICF = Informed Consent Form
“Subject” can be used interchangeably to refer to either the actual subject or the subject’s legally authorized representative.

Standard Written Consent: "Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form."

In Short: ICF including all elements of informed consent read by and signed by subject. A copy must be given to the subject.

Oral Consent: "A short form written consent document stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form."

In Short: PI prepares a consent document which he or she reads to the subject. This must be signed by the PI and the witness. PI also prepares a short form consent document which simply states that the consent document has been presented to the subject. This must be signed by subject and the witness. Copies of both the verbal consent document and the short form consent document must be given to subject.

Waiver of Documentation: "An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1)That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or (2) 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. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research."

In Short: ICF including all elements of informed consent read by but not signed by the subject. An information sheet must be prepared and given to the subject. Also, PI must include the Waiver of Documentation of Informed Consent and submit it with the protocol application.

Children

In the case of minors (under 18), parental permission must be obtained. The parental permission documents are created using the guidelines outlined above for adult consent forms. 

Standard Written Assent: The equivalent of the Adult Standard Written Consent. However, it must be worded in an appropriate manner to meet the needs of the age, maturity and psychological state of the children involved. It must be signed by the child and a copy given to the subject as well.

Oral Assent: The equivalent of the Adult Short Form Consent. Both the verbal presentation of the consent form and the short form consent document to be signed by the child and a witness must be in a language appropriate for the age, maturity and psychological state of the child. The verbally presented document must be signed by the PI and the witness. Copies of both should be given to the subject.

Waiver of Documentation: The equivalent of the Adult Waiver of Documentation. It is an ICF including all elements of consent in a language appropriate for the age, maturity and psychological state of the child to be read by the child but not signed. An information sheet must be prepared and given to the subject. Also, PI must include the Waiver of Documentation of Informed Consent form and submit it with his/her application.

Non English Speaking Subjects

In the case of non English speaking subjects, consent forms are prepared following the guidelines above for adults and children. Only the English versions must be included in the original protocol submission to the IRB but upon approval they must be translated into the language(s) of the subject pool. In addition, the PI must submit a Certificate of Translation.

Waiver or Alteration of Some Elements of Informed Consent

In certain cases, changes may need to be made to the basic elements of informed consent as required by 45 CFR 46.116(a). To do this, ALL of the following must be true: (1) The research involves no more than minimal risk to the subjects, (2) The alteration will not adversely affect the rights and welfare of the subjects, (3) The research could not practicably be carried out without the alteration, and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If you would like to apply to alter the consent process and you determine that your research meets all of the qualifications listed above, fill out the Request for Waiver or Alteration of Elements of Informed Consent.

Waiver of the Informed Consent Process

In certain cases, the PI might want to waive the consent process all together. To do this, ALL of the following must be true: (1) The research involves no more than minimal risk to the subjects, (2) The waiver will not adversely affect the rights and welfare of the subjects, (3) The research could not practicably be carried out without the waiver, and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If you would like to apply for a waiver of the consent process and you determine that your research meets all of the qualifications listed above, fill out the Request for Waiver of the Informed Consent Process.