Guidance: Telephonic Consent
In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol, including its risks, benefits, and alternatives. The subject's voluntary and uncoerced choice to participate must usually be documented by the subject's signature on the approved consent form. The Department of Health and Human Services has, however, developed special rules permitting an IRB to approve, under limited circumstances, alternative forms of consent or waiver of documentation of consent.
Waiver of Standard Documentation Requirements: Special Rules for "Telephonic" Consent
Consent Provided By A Subject
An IRB may require the process of consent but waive the requirement for the investigator to obtain a signed consent form for some or all subjects. This provision allows for consent to be obtained verbally, by phone.
In order to approve this process, the IRB must find and document 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 (applies only to non-FDA regulated research) In this case, each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes must govern;
The research presents (i) no more than minimal risk of harm to subjects; and (ii) involves no procedures for which written consent is normally required outside of the research context. (This exception applies to FDA and non-FDA regulated research).
Where PHI is involved , the IRB must also find that there is no more than minimal risk to the privacy of individuals and that the research could not practicably be conducted without the waiver and without the requested use or disclosure of PHI.
When the consent documentation requirement is waived in this circumstance, the IRB may require the investigator to provide the research subject with a written statement concerning the research. When making a request to use telephonic consent, the telephone script (the planned text to be used by the researcher making a call) must be included in the application for IRBMED approval.
Consent Provided By A Subject's Representative
The IRB may approve a telephonic consent procedure under which the subject's legally authorized representative ("LAR") is sent a faxed/emailed version of the informed consent document, a consent interview is conducted by phone while the LAR has the document in hand, and the LAR signs and returns the signed document to the investigator by return fax before the subject is enrolled in the study. In cases where this process is used, a witness who is not connected to the study (e.g., as an investigator, coordinator, etc.) should monitor the consent process.
For more details on the criteria that must be met in order for the IRB to approve a telephonic consent process, please review the Waiver or Alteration of Written Informed Consent under OHRP, FDA, and HIPAA Regulations.
Telephone Consent Terms
Representative: Representative means the subject's legally authorized representative ("LAR"); a person recognized by law because of a spousal or familial relationship or by legal documentation such as 'Power of Attorney' to make decisions for another patient and/or subject. Consult with the Health System Legal Office for guidance regarding who may serve as a legally authorized representative.
Practicably: Federal regulations do not define the word 'practicably'. Black's Law Dictionary, on which courts sometimes rely in interpreting legislative or administrative agency intent, defines the term as: "reasonably capable of being accomplished; feasible."
Emergency exception: The Food and Drug Administration has recognized an extremely limited emergency exception to standard informed consent requirements, applicable only in certain emergency life-threatening situations where standard therapies are unproven or unsatisfactory and significant administrative burdens are met by the relevant investigators and IRB. As a matter of policy, IRBMED currently does not permit waiver of consent in emergency situations. An explanation and discussion of this policy is available by clicking here.
Minimal risk to the subjects: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
- sent or stored in any form;
- that identificies the patient or can be used to identify the patient;
- that is created or creceived by a covered entity (e.g. hospital, doctor, dentist, health plan);
- that relates to a patient's past, present and/or future treatment and payment of services.
- USE: generally refers to how PHI is handled (internally)
- DISCLOSURE: generally refers to how PHI is shared externally.