Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.
So what are some the similarities?
- Both of the consent processes, for research or for standard of care treatment, i.e. surgery, are to ensure the safety of the patient or potential subject. An informed consent allows an individual to be autonomous.
- Both are to notify the patient or subject of the potential risks or adverse events
- The consent process entails a discussion providing the details of exactly what will happen to the subject or patient during the procedure
Ultimately, an informed consent for research or non-research procedures is to protect the individual and provide them knowledge and details regarding what could happen to them if they agree to participate.
What are some of the differences?
- The basic element of each type of informed consent form varies.
The required elements of a consent for research can be found here (21 CRF 50.25). Many research consent forms are several pages long containing all of the required elements. The FDA provides specific criteria as to what should be physically included in the actually document. Monitors at IMARC thoroughly review all informed consents for research to ensure that all of the FDA mandated elements are present as discussed in this previous blog.
A non-research informed consent document is much different (42 CRF 482.51). An informed consent for non-research procedures can be a one page generic document, containing a blank line where the physician will write in the type of procedure to be performed with his/her name as the performing surgeon and contain a generic statement that the individual has been explained: Diagnosis, Purpose of proposed treatment, Possible risks/benefits, Alternative treatments and Possible risks of not receiving treatment. It is up to the physician to discuss each of these topics pertaining to the procedure that the patient may undergo. The details are not always written out in the document, just a statement that your physician has discussed the details. Of course, this can vary hospital to hospital and state to state. The consent then has a line for the patient’s and witness’ signature and date.
- The IRB has to approve a specific informed consent form for each research study. The IRB as the responsibility of overseeing the trial at the particular site. Whereas hospitals have their own approved informed consent that may or may not be procedure-specific for treatment.
- During the research consent process, any financial disclosure must be presented to the potential research subject and must be spelled out in the informed consent form. This is given to the subject to provide information regarding the compensation that the investigator is receiving and the financial interests of the physician conducting the study. For non-research procedures within a hospital this is not included within the consent process.
As many research study personnel have non-research responsibilities at the site in which they are employed, it is important to be able to recognize and switch gears when performing tasks related to research and know what the regulations dictate when it comes to research. Not doing so can lead to informed consent errors. Do you have examples of this? Please share them with us!
Photo Credit: Keith Williamson