Informed consent is required for receiving any type of medical intervention, including drugs, surgeries or therapies, and for involvement in any type of human research. Each of these, however, are two different types of informed consent with different requirements. The US Department of Health and Human Services has a list of what’s required for informed consent to participate in human research, and Medline provides a list of what informed consent involves when it comes specifically to receiving medical care independent of research.
Deeper dive: Informed consent for clinical research
If a patient receives any type of experimental intervention or is going to participate in a clinical trial, they must receive an explanation of any potential risks or harms involved in participation — whether from the intervention itself or from being observed or recording an activity — as well as the potential benefits of involvement, how the individual’s privacy will be handled, any relevant confidentiality clauses, how the study will be conducted and how the results will be used.
The U.S. Department of Health and Human Services has a list of what’s required for informed consent to participate in human research. In its most basic form, there are three parts:
First, participants must be provided a document, called the consent form, that describes the research project.
Second, participants must have an opportunity to ask the researchers questions about the study and your participation in it. They may be provided with additional information in documents or in videos that might answer questions as well.
Third, participants sign the consent form to indicate that they understand the project and the benefits and risks associated with it, and they agree to participate. If the participant is a minor, informed consent must be provided by at least one parent (sometimes both, depending on the state, the research and case law). Usually, if the participant is a minor but old enough to understand the procedure and the risks and benefits, researchers seek assent from the participant.
The consent form must provide the following information:
- A statement that the study involves research.
- Why the research is being done.
- How long the person will be participating in the study.
- A description of the procedures to be followed during the study.
- Identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
For research involving more than minimal risk, an explanation about whether the participant will receive any compensation and whether any medical treatments are available if injury occurs, and what they involve (and/or where the patient can get information on that).
Research, Rights or Injury: An explanation of who to contact for answers to questions relevant to the research and research participants’ rights, and who to contact if the participants experiences an injury related to the research.
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits that the participant is otherwise entitled to receive.
These additional elements may be required during informed consent, usually as determined by an Institutional Review Board:
- A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the person is or may become pregnant) which are currently unforeseeable.
- Anticipated circumstances under which the person’s participation may be terminated by the investigator even without the participant’s consent (such as if a negative side effect shows up that makes the study too dangerous to continue).
- Any additional costs to the participant that could result from participation in the research.
- The consequences of a subject’s decision to withdraw from the research and the procedures for ending their participation.
- A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject.
- The approximate number of subjects involved in the study.
Deeper Dive: Informed consent for health care procedures
Informed consent for a medical procedure is required for most types of medical intervention, including most surgeries in any setting, any type of screening or diagnostic test, any imaging (such as an X-ray or MRI), blood tests, and taking a medication or receiving a vaccine.
Medline provides a list of what informed consent involves when it comes specifically to receiving medical care independent of research. There are five basic components:
1. A description of the treatment (the medication, surgery, procedure, therapy or other intervention).
2. The risks and benefits of that treatment.
3. Alternatives to that treatment for the same problem.
4. The risks and benefits of the alternatives.
5. Ensuring that the patient understands the first four items (description, risks and benefits, alternatives and risks and benefits of the alternatives) and is therefore capable of deciding whether they want to receive the treatment.
As part of those five components, patients must be informed during the informed consent process what will happen during the procedure, why the procedure or treatment is needed and for what condition, how necessary or immediate the procedure is and how likely the procedure is to work or not.
For most vaccines, informed consent involves giving patients the appropriate Vaccine Information Statement for all the vaccines they’ll receive. Each VIS is a uniformly designed form created by the CDC for all recommended vaccines. For medications, there are often two indirect layers of informed consent, depending on the state: the prescribing clinician and the pharmacy if state law requires pharmacist counseling before a patient can pick up a certain drug.
There are times when informed consent for a medical procedure is not necessarily. These include emergency situations where delaying the treatment even for seconds could be life-threatening or when the person is unconscious and unable to consent but will likely die or experience permanent disability without immediate treatment. Ideally, a family member or someone with power of attorney can provide informed consent for someone who is incapable of providing it themselves, such as if they are unconscious or there is no identifiable way to communicate. In this rare cases, a hospital ethics board often becomes involved to determine if moving forward with the procedure is appropriate and ethical.