We are asked to provide our consent numerous times a day in this era of GDPR. Every time we visit a new website, we mindlessly consent to cookies that will track our internet activity and know which advertisements to flash on our social media. Patient informed consent is a recent concept. It became formally recognised in medical treatment in the 1950’s1and more seriously considered in research in the 1970’s2.
In a recent MS Journal Club, I presented an article3 about patient involvement in research. You can read about it in this blog post. This then prompted the discussion about research bureaucracy, patient information sheets (PIS), and the standard of consent. Patient information sheets are often long, text heavy documents that are impossible to understand. They are intended to provide all the information about a study to patients (risks/benefits/how your data is managed/how to withdraw, etc.) – but this isn’t the case. Researchers must complete these forms to meet regulator, legal and ethical requirements. Forms that were developed decades ago, have never been updated with strict sections and headings that can’t be altered, or they won’t be approved.
This raised a lot of questions: Does the information contained in a PIS matter? How many patients read (and understand) an entire PIS before consenting to research? How can we make PISs more understandable and accessible for patients? Does having a simple PIS co-produced with patients mean that people are more likely to join research studies? What does full consent look like, and is a degree of consent sufficient?
YES – and we need to get better at explaining and obtaining it
I am not a clinician. My background is working in the voluntary sector, regulation and research. Since I’m not delivering clinical research, I don’t take blood tests, lumbar punctures or give you medication with potential side effects. My experience of obtaining informed consent is outside of a clinician-patient relationship based on trust: that this treatment or clinical study will benefit you. I often have never previously met the people who I interview and will likely never speak with them again. I am requiring them to trust that I will ask appropriate questions, use, and protect their data and information accordingly. Often the first contact I have with potential participants is emailing them a PIS and consent form. These forms are what I need to use to convince people to participate in my research. Additionally, remote working has removed me further from the consent process, where I could previously review and sign the forms in person with participants, I now take their electronic signatures as their full consent.
I learned from one of my recent consent forms how confusing they can be. This consent form had a list of statements which the participant had to sign individually to agree with each statement. I had worded all the statements to be positive based on a standard template e.g. “I agree for the focus group to be recorded” apart from the last statement which was a negative one “I don’t agree to participate in the focus group”. In hindsight, the last statement shouldn’t have been included, or should have been reworded to be positive since it contradicted all previous statements. Nearly half of the consent forms that I received, the participants had signed all the statements including the last, which I assumed meant they hadn’t clearly read/understood the (unclear) consent form.
Should patients be involved in developing research documents that are sent to participants? Perhaps if I had the time and opportunity to have a patient and public involvement (PPI) group review the consent form, they would have pick this up and provided suggestions and improvements to make it even easier to understand. I would like to believe that each participant has fully read and understood all the documents I send to them. Even if this may not be the case, it’s still essential we provide people with as much accessible information as possible prior to them consenting to participate in research.
What can YOU do to help?
The NIHR is doing a call for evidence on research bureaucracy for anyone who would like to give feedback by 1 October 2021: https://www.gov.uk/government/consultations/independent-review-of-research-bureaucracy
Disclaimer: Please note that the opinions expressed here are those of the authors and do not necessarily reflect the position of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust.
Heather Mah is a PhD researcher at the Wolfson Institute of Population Health at Queen Mary University London exploring the experiences of people with MS and healthcare professionals involved with Patient and Public Involvement (PPI).
- Katz, Jay. The silent world of doctor and patient. JHU Press, 2002.
- Beauchamp, Tom L. “Informed consent: its history, meaning, and present challenges.” Cambridge Quarterly of Healthcare Ethics 20.4 (2011): 515-523.
- Dwyer, Christopher P., et al. “A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial.” Journal of Health Psychology (2021): 13591053211037736.
I’m not sure if your PCFs would meet NIHR criteria if patients were involved in drawing them up, but it is a good idea in principle. If patients are involved, they feel more comfortable. I’m up for it as I arrogantly think I could do a good job, but what do I know?
Having lived experience makes you more of an expert than any researcher or clinician!
But isn’t it good to include a question/statement to ensure that patients/participants have actually read the text of what they are signing?
Not sure that would guarantee they had.
Absolutely, which was covered in the above questions
From what I’ve heard children of medical professionals like to get involved with PPI. Especially in London, doctors children will gain experience in PPI, which might assist them with their own application to medical school. If they follow in their parents footsteps and become a clinician.
Interesting, I hadn’t thought about this
On one hand many clinicians become service users or patients themselves, sometime in their lives, such as through pregnancy and childbirth. So they might have lived experience.
Regarding the children of clinicians getting involved in PPI, I wonder if this causes bias in any way?