Question

Research on new medical technologies requires informed consent from participants in the studies.Discuss the four areas required to have informed consent.

Answer 1

There are 4 components of informed consent:

You must have the capacity (or ability) to make the decision.
The medical provider must disclose information on the treatment, test, or procedure in question, including the expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur.
You must comprehend the relevant information.
You must voluntarily grant consent, without coercion or duress.

Decision-Making Capacity

Decision-making capacity is often referred to by the legal term competency. It is one of the most important components of informed consent. Decision-making capacity is not black and white. You may have the capacity to make some decisions, but not others.

The components of decision-making capacity are as follows:

The ability to understand the options
The ability to understand the consequences of choosing each of the options
The ability to evaluate the personal cost and benefit of each of the consequences and relate them to your own set of values and priorities

Disclosure

In order for you to give your informed consent for treatment or tests, the doctor or health care provider must give (or disclose) to you enough information so that you can make an informed decision. It is not necessary or expected that you would receive every detail of the test, treatment, or procedure. You need only the information that would be expected by a reasonable person to make an intelligent decision. This information should include the risks and likelihood (or probability) of each of the risks, and the benefits, and likelihood (or probability) of benefit. Any questions you have should be fully explained, in language and terminology that you can understand.

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Documentation of Consent

For many tests and procedures, such as routine blood tests, X-rays, and splints or casts, consent is implied. No written documentation of the consent process is obtained. For many invasive tests or for treatments with significant risk, you should be given a written consent form and a verbal explanation, both preferably in your native language.

The following components should be discussed and included in the written consent form. If they are not, you should request that information:

An explanation of the medical condition that warrants the test, procedure, or treatment
An explanation of the purpose and benefits of the proposed test, procedure, or treatment
An explanation or description of the proposed test, procedure, or treatment, including possible complications or adverse events
A description of alternative treatments, procedures, or tests, if any, and their relative benefits and risks
A discussion of the consequences of not accepting the test, procedure, or treatment

The consent form should be signed and dated both by the doctor and by you, as the patient. You would sign for your child. You may ask for a copy of the signed consent form.