GUIDELINES FOR THE INFORMED CONSENT PROCESS
There are four consent options:
- Written Consent
- Short Form
- Waiver of Documentation
- Waiver or Alteration of Consent
(1) Written Consent
Basic Elements and Additional Elements of Consent: Unless otherwise authorized by an IRB, research investigators must provide the following information to each subject in writing: http://www.hhs.gov/ohrp/policy/consentckls.html
To enhance comprehension and readability, investigators are strongly urged to use a format in the body of the consent form that presents information in sections, introduced by headings, that clearly simply, identifies and describes each of the elements to be discussed.
(2) Short Form Consent
The alternative "short form" method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English-speaking subject in a study for which no consent form in the subject's language has been prepared. Routine use of the "short form" for obtaining informed consent is strongly discouraged.
When using the short form method, investigators must provide the following information to each subject in writing:
A 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.
(3) Waiver of Documentation of Informed Consent (waiving the signature requirement)
The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects if it finds either:
- 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
- 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.
(4) Waiver or Alteration of Informed Consent (46.116):
The IRB 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 provided the IRB finds and documents that:
- the research involves no more than minimal risk to the subjects:
- the waiver or alteration will not adversely affect the rights and welfare of the subjects;
- the research could not practicably be carried out without the waiver or alteration; and
- whenever appropriate, the subjects will be provided with additional pertinent information after participation