“A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or prentice procedure”
Standard #9 provides more details on informed consent, emphasizing this as an educational process based on shared decision-making. This standard does not provide a list of procedures that require informed consent.
If you are thinking of “informed consent” as the signature on a piece of paper, the answer is either yes or no for a midline catheter insertion based on the direction of your risk management department. They will know about any applicable state laws regarding informed consent. Risk management’s decision should be included in your policy and procedure for midline catheter insertion.
I would also encourage you to broaden your thinking about informed consent. This is an educational process that ends with a signature on a piece of paper but the patient’s adequate knowledge comes from what they are taught, preferably by the midline inserter who would have the most current and accurate knowledge about this procedure.
The educational component of the informed consent process is always required for all procedures and all patients in all situations. Even if your facility does not require a signature on that consent form, you should still be educating the patient about the catheter, why they need it, what the procedure will entail, risks, benefits, and complications. If a signed consent form is required, the education must also include alternatives to the proposed midline catheter.
So, the possible answers are
- Yes - a signed consent form is necessary based on your risk management decision and applicable state laws. The guiding thoughts in this decision usually include the fact that this is an invasive procedure and the length of time the catheter may remain in place can be several weeks.
- No – a signed consent form is NOT necessary because this procedure is covered in the general consent signed at admission. This is usually based on the concept that this catheter lies only in peripheral veins and does not have the same level of risk as a central venous device.
Both approaches still require patient education. The INS standard on informed consent includes 9 criteria for appropriate education for the patient’s age and level of health literacy. Please check out this standard for the details.