Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment.
It originates from the legal and ethical right the patient has to direct what happens to his or her body and from the ethical duty of the physician to involve the patient in his or her health care.
The essential elements of informed consent include:
- Reasonable alternatives to the proposed intervention
- The relevant risks, benefits, and uncertainties related to each alternative
- The nature of the decision/procedure
- Assessment of patient understanding
- The acceptance of the intervention by the patient
- Reasonable physician standard: what would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. However, this standard is often inadequate, since most research shows that the typical physician tells the patient very little. This standard is also generally considered inconsistent with the goals of informed consent, as the focus is on the physician rather than on what the patient needs to know.
- Reasonable patient standard: what would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a typical patient would need to know in order to understand the decision at hand.
- Subjective standard: what would this particular patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.
Benzodiazepine Prescribing, Deprescribing, Reinstatement and Updosing Requires Informed Consent
Before initiating or stopping benzodiazepines—or attempting to updose or reinstate after too-rapid tapering or abrupt discontinuation—patients should be fully informed of the risks and uncertainties so they can provide informed consent. These medications can cause physical dependence and a complex withdrawal syndrome in some individuals, and decisions regarding their use should be made with full awareness of the potential risks and uncertainties.
Informed Consent for Initiating or Deprescribing Benzodiazepines
Patients considering starting a benzodiazepine should be aware of:
- The risk of physical dependence, which can occur quickly—even when used as prescribed.
- Withdrawal symptoms that can be protracted, severe, and life-altering.
- The lack of adequate prescriber education around deprescribing and withdrawal risks.
- That benzodiazepines are often prescribed long-term despite guidelines recommending short-term use only.
Likewise, patients considering tapering or discontinuing a benzodiazepine should understand:
- The importance of a slow, individualized taper.
- That rapid tapers, cold-turkey discontinuations, or forced detox protocols can cause significant neurological distress and disability.
- That benzodiazepine withdrawal can result in a syndrome called BIND (benzodiazepine-induced neurological dysfunction), which may persist for months or even years.
Read our informed consent document for initiating or deprescribing benzodiazepines. This printable version includes references and is designed to be used in clinical practice. Clinicians are encouraged to review it with patients, have both parties sign, and retain a copy to ensure that the patient is giving truly informed consent. It is free to use provided the authors are credited and the content is not altered.
Authored by Benzodiazepine Information Coalition and the Alliance for Benzodiazepine Best Practices.
Informed Consent for Reinstatement and/or Updosing
Some patients who have tapered too rapidly or abruptly discontinued benzodiazepines or other psychiatric medications may consider updosing (increasing a dose they previously reduced) or reinstating (starting the medication again). This is often done in an attempt to stabilize or alleviate withdrawal symptoms. However, these strategies carry their own risks and are not guaranteed to succeed.
Before pursuing reinstatement or updosing, patients should be aware that:
- Outcomes are highly unpredictable. Reinstatement may fully resolve symptoms, partially help, or have no effect at all.
- In some cases, reinstatement or updosing can cause paradoxical effects—such as worsened symptoms—including agitation, anxiety, or akathisia.
- The timing of reinstatement plays a critical role. Generally, the sooner after discontinuation, the better the chance of success.
- A test dose (a very small initial amount) is often advised to minimize risk.
- Even if successful, future tapering must be done more cautiously, and subsequent withdrawal attempts may be more difficult.
We’ve developed a detailed informed consent document specifically for this purpose, co-authored by clinicians and experts in psychiatric deprescribing.
Read the Informed Consent for Reinstatement and/or Updosing of Psychiatric Medications. This printable version includes references and is designed to be used in clinical practice. Clinicians are encouraged to review it with patients, have both parties sign, and retain a copy to ensure that the patient is giving truly informed consent. It is free to use provided the authors are credited and the content is not altered.
This informed consent document was developed through the collaborative efforts of Benzodiazepine Information Coalition and Antidepressant Coalition for Education. Individual contributors include:
Dr. Louise Bundock – Psychiatrist, Special Interest in Deprescribing
Janice Curle – Co-founder, Benzodiazepine Information Coalition
Mark Horowitz, MBBS, PhD – Clinical Researcher, Lead Author of The Maudsley Deprescribing Guidelines
Nicole Lamberson, PA – Medical Director, Benzodiazepine Information Coalition
Morgan Stewart – Founder, Antidepressant Coalition for Education
These consent documents are designed to protect patient safety, promote shared decision-making, and ensure individuals have the knowledge needed to make fully informed choices around benzodiazepines.