Self-advocacy and informed consent in IVF Treatment
This is a little bit heavier than some of our other articles. But in our opinion possibly one of the most important!
Well fertility treatment is complex, it is involved, it’s individualised, it’s emotional, it’s stressful and elements of it aren’t as regulated as you would expect, especially in the private sector of the IVF world, which means that it is vital you speak up for yourself and understand exactly why treatment options are being proposed and what the risks, benefits and evidence is all about.
This leads to emotional selling and poor practices with less focus on patient need.
Through our website and speaking with people going through IVF treatment, we have spoken to many patients who went into their initial consultation having a list of add-ons costing £1,000’s which their infertility and assisted reproductive histories didn’t warrant. They would have more than likely had similar chances of success on a standard IVF protocol.
The clinicians didn’t highlight this to them!
Firstly, in order to understand what this article is about we need to understand what self-advocacy and informed consent mean.
What is self-advocacy
This is defined as
“The action of representing oneself or one’s views or interests.”
Seems like a pretty simple concept, and ultimately it means
- Speaking up for yourself and the areas which are important to you
- Tell people what you want and need
- Explain how you are feeling
- Understand your rights and responsibilities
- Ultimately it is for you to decide what you want and need and come up with a plan on how to achieve this.
Essentially, it’s about knowing what you want to achieve, what journey entails, asking applicable questions and feeling supported. We will go into more of this in later sections
What is informed consent?
Again, starting with a dry definition:
“Permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits.”
Again this seems pretty obvious. However…
Ask yourself this.
You don’t have 5-year medical degree and another 7 years of specialty training: How do you go about truly understanding the risks, benefits, evidence and accuracy of information?
The honest answer is we have to trust our clinicians… so is this really ‘informed’ consent if we don’t have the information required to make an informed decision as to the right way forwards?
Is consent informed if we don’t know all the facts?
Why are self-advocacy and informed consent even more important in reproductive medicine and IVF?
Ok let’s start with something completely different to IVF.
You’ve had a heart attack; you need a stent and you need to be on Aspirin, a statin and anti-hypertensive medications for the rest of your life.
You’re admitted to hospital:
- your doctor is clear with you that you had a heart attack… this diagnosis is from interpretations of a heart trace, blood tests and an angiogram
- You are told that if you don’t have the stent, you will have another heart attack and the possibility of death is high, you are warned that there is a rare chance that you could have another heart attack or die on the operating table
- You sign the consent understanding the benefit and risk
- You go to surgery – it’s successful
- You recover, are moving around the next day and released with clear instructions of medications you need to take when and what doses as well as regular follow ups in the community and the hospital
- You take the medications and live for years with no problems
Let’s take a more detailed look at each of these steps and see how they differ so hugely from another medical procedure IVF.
Point 1 – Diagnosis
In the heart attack the diagnosis is clear and NICE guidelines dictate the specific course of action based on your condition and the cause of it.
Those referred from and fertility clinic to IVF can have a huge range of conditions from endometriosis, PCOS, early ovarian failure, Genetic Disorders, Male Factor infertility, blocked Fallopian tubes and even ‘Unexplained Infertility’ a condition which means couples have problems conceiving but there is no obvious reason for it. The majority of these are then treated using 1 intervention….
Sometimes when you put it down on paper it feels like shoe-horning a square peg diagnosis into a circular shaped treatment hole and hoping it works. So, as you can see the treatment is not always exactly defined for each diagnosis and this is important as we move through the discussion.
Point 2 – Gaining consent
With the hear attack it’s pretty clear the consequences of a particular action are fairly well defined, and the treatment plan is obvious, this makes the discussion between patient and clinician fairly simple to understand as long as plain language backed up with written documentation is used. The patient can make an informed decision to either risk highly probable death through no treatment or a low chance of death with improved quality of life if they choose treatment…
but the patient understands this choice and can choose. This is Informed consent.
With IVF things are different:
You have a diagnosis which means you are told you require IVF, however this treatment only about 29% successful. You have already tried for years, you are already emotionally drained, you want children!
You live in an area which only has 1 attempt on the NHS you went through this and it failed so you decide to go private.
You’ve been surfing the web and reading about PGS, reproductive immunology, Embryo Glue, assisted hatching and you decide you want it all because you want to have the best chance of having a child. Read our series on IVF add-ons if you want to learn more and review the latest evidence.
Now if you are at a good clinic they will look at your fertility diagnosis, run a few tests and explain why these options are not right for you and that even if they ‘might’ be right for you the current evidence doesn’t support the use of these interventions in your circumstances, and tell you about the additional risks associated with some of these; so advises against it and you agree going with a bespoke protocol to your hormonal levels and saving yourself £1,000’s in the process (for all of these you could save enough for another full cycle or even 2 in some circumstances). Again, this would be informed consent and you asking about other options is you advocating for the best outcome.
However, what you may not know is that:
IVF add-on treatments aren’t regulated in the same way as many treatments, their prices aren’t regulated, and they don’t have to have a strong evidence base to support their use in almost all cases!
As such many clinics offer these on their ‘menu’ of services and the only time you may hear about the risks, lack of evidence is in the small print of your contract – This is not an uncommon practice.
The initial appointment will often focus on selling you on the benefits of the additional treatment option and gloss over the risks and evidence. Further supported with glossy marketing materials with pictures of happy couples with babies! This leaves patients with a very one-sided view of these treatments… so they consent…
This is NOT informed consent.
This problem is further exacerbated by the fact that our regulatory body the HFEA only have about 150 words on each and traffic light system- this leads people to rely on google for more information, which is filled with misinformation, anecdotes masquerading as facts and the trials which have been done in complex language, which lay individuals can find hard to interpret.
The result leads to an un-informed group of patients which are forced to trust institutions, clinics and clinicians in a big business environment when they are already vulnerable to emotional selling.
This is not acceptable
Point 3 – Consent forms
You sign the consent to treatments form based on the weak information we discussed above.
Just to re-iterate this is unlikely to be informed consent if full information is not disclosed in a clear and accurate manner
Point 4 & 5 – Treatment outcomes
You go through the treatment, hopefully without getting OHSS and 70% of the time it is unsuccessful.
Now although you ‘think’ as a patient you understand these odds….
Hope can be a blinding issue
Unfortunately, this can mean that you have to repeat the process spending many thousands more. It can cause a severe decline in mental health in already vulnerable people and this is another area which is often not discussed – Clinics are supposed to offer fertility counselling as part of IVF however this is often an additional cost after 1 session.
Point 6 – Life after IVF
If you have had successful outcome then life can be wonderful, happy and leave you fulfilled. However, many people having had successful treatments still have problems in life. Having had to have had help to create a child leaves some feeling guilty, useless, non-worthy and a number of patients continue to have mental health problems including clinical depression over the course of their lifetime due to infertility. This is another area which is almost NEVER discussed through the IVF process.
Many others who are unsuccessful must consider a life different to that which they have dreamed and aspired and worked for many many years and sometimes decades to achieve. It is grief, it is loss and people can never recover fully and live painfully with the consequences of this ‘miracle’ treatment not working.
You may realise that we feel very strongly about this subject. I think that the reason that informed consent and self-advocacy for IVF and infertility is so important is that it’s not as clearly defined as other medical conditions.
Which often means the treatment pathways are more open to interpretation and when this is coupled with lower regulatory requirements and potential of huge sums of money: This is a recipe for emotional uninformed selling of treatments with sugar coated benefits and glossed over risks. People can’t make informed consent.
What does this mean for patients and how can you overcome this?
This is where self-advocacy comes in!
See we got there eventually.
What do we mean by this? Well as you have read above because the treatment pathways aren’t as clearly defined and regulations on treatments aren’t as tightly controlled as in other medical conditions. This means you will be offered a range of treatments often called protocols.
You already know what you want to achieve and that is a pregnancy which leads to a live birth.
You should know what is important to you and you should right these down before you go to your initial consultation these can be things like
- Minimising the risk of OHSS as much as possible
- A more natural IVF cycle
- A fear of operations
Finally, you should completely understand and agree that the treatment plan fits with what you want. Remember to also think about the stimulation protocols as these differ from patient to patient and clinic to clinic so it’s worth asking why they selected the specific doses and medications and whether there would be any benefit/risks to amending these to a more or less aggressive protocol.
By asking lots of information, corroborating that information you are advocating for yourself and this will help you make informed consent.
How well do NHS funded IVF treatments perform regarding informed consent?
Overall, I think NHS Fertility clinics do a pretty good job of informed consent. I believe there are 5 core areas where there could be better information and discussion.
- I believe that there should be a stronger and more robust information and discussion around the mental health and emotional impacts of both successful and unsuccessful cycles. Coupled with clear access to support both professional and peer to peer.
- Death or incapacitation of a female partner means the eggs if they are frozen cannot be used by the man of the couple to create children in the future, whereas the sperm can. When I asked for more information, I was told this would need to discuss this with a solicitor and it would delay our treatment. This is something that should be discussed at the initial appointment not on the return of the form during implications, so that couples have a better opportunity to explore this if desired.
- Protocol variation – It seems that some NHS led IVF clinics have very specific down regulation and stimulation protocols, which will work for some may not be optimal for many. As such I think more time should be dedicated to discussion regarding the risks and benefits of differing protocols within the bounds of safety.
- Additional time should be dedicated to the medication side effects and the impacts these have on the body, mind and relationships.
- If patients are participating in random clinical trials – which I would advocate patients to do so. Then clear information about the current state of evidence and an honest overview of known risks. It’s also important that a patient clearly understands what a placebo treatment or medication is.
All of these are assuming no additional add-on treatments are being used – if they are then these need to be discussed in individualised terms specific to the patient’s infertility and the benefits of the additional treatments and tests.
Informed consent is a two way process a patient has a responsibility to get the information they need to make an informed decision. A clinic or clinician are responsible to ensure that information is clearly available, honest and unbiased. Finally, a clinician should speak up when they believe a treatment is not in the patients’ best interest or the evidence is non-supportive of use in their circumstance.
This is where the problem stems. The fact that non-evidence based (having not gone through RCT’s (Randomised Clinical Trials)) treatments are able to be offered to patients. Clinics are not as stringently regulated on these and this includes their marketing materials. Finally, they aren’t audited in a detailed enough manner regarding selling, paperwork, success rates and clinical reasoning for interventions offered.
We believe that if regulatory powers were extended by the government to the HFEA and clear information about current evidence is presented without the science and maths speak to patients, then informed consent would become a much less common problem in assisted reproduction.
But as it stands it is a dark cloud hovering over an industry which in most cases wants to do the best for patients.
Let us know your thoughts on self advocacy and informed consent in regard to IVF we’d love to know what you think.