Background
A few days ago, I had some disappointing news. I have been working on my PhD in the area of digital selfcare and self-tracking in Parkinson’s disease since 2012, which is probably starting to be a bit too long. I was therefore very happy to be able to submit my application to defend my thesis before the university went on summer holiday. In the application I aimed for thesis defense in late November, the examinators and the opponent had confirmed their availability and I was starting to look forward to D-day. Of course I was well aware of the potential obstacles that were left to clear. The vetting of an application to defend a doctoral thesis at my university entails two separate parts. The first part checks things like that any of the supervisors (current or previous) have not published anything with any of the examiners or the opponent and that the scientific articles that the applicant wants to include in her thesis are of sufficient quality and extent to be equivalent to at least four years full time work. The main supervisor also submits her statement of the doctoral student’s learning process and development during her time as a doctoral student. The second part of the vetting is dedicated to ethical aspects.
Ethics is of course an essential part of medical research and the Wikipedia entry for “medical ethics” begins:
Medical ethics is a system of moral principles that apply values to the practice of clinical medicine and in scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal without any conflict. It is important to note that these four values are non-hierarchical, meaning no one principle routinely “trumps” another.
Ref: Wikipedia contributors. (2018, September 12). Medical ethics. Wikipedia, The Free Encyclopedia. Retrieved 17:54, September 13, 2018, from https://en.wikipedia.org/w/index.php?title=Medical_ethics&oldid=859196395
If you are interested in the long history of medical ethics, I recommend reading more in the Wikipedia entry. For now I want to focus on the implementation of medical ethics in research in Sweden.
Ethical aspects of medical research in Sweden are regulated by The Act (2003:460) concerning the Ethical Review of Research Involving Humans (Lag (2003:460) om etikprövning av forskning som avser människor) and The Statute (2003:615) concerning the Ethical Review of Research Involving Humans (Förordning (2003:615) om etikprövning av forskning som avser människor). Unofficial translations into English can be found here.
These regulations are the basis for ensuring that medical research in Sweden is conducted in an ethical manner. When I read the legal text, it seems clear to me that ‘medical research’ in the eyes of the law is conducted in a clinical setting, probably a hospital, the researcher is most likely a person with clinical training (physician, nurse, physiotherapist or similar) and the research subject is a patient. The regulations, when applied in such a context, probably does a pretty good job at protecting unknowing patients from being taken advantage of by ‘overly creative’ researchers, and that is a good thing. But what if the research in question is not conducted in a clinic but instead aims to explore patients’ selfcare? And what if the researcher is in fact not clinically trained but a patient? And finally, what if the research subject and the researcher are one and the same? Is it reasonable to expect that the same regulations can be applicable?
The Dissertation Committee’s decision
The disappointing news I had were that the Dissertation Committee rejected my application to defend my doctoral thesis. The Dissertation Committee’s decision was (my translation):
Due to the unusual circumstances of this case a more comprehensive review of your application has been made. The primary focus of this process has been the issue of ethical approval and the conclusion is that The Ethical Review Act does not make exceptions for research on persons who themselves are scientifically involved in the study. It should be noted that the reviewers of the doctoral student’s halftime review issued a “strong recommendation” to go through all ethical approvals.There is no ethical approval for paper I [my comment: paper I is published and can be found here]. In the article, the authors describe it as a case study that was conducted without intention to publish. For case studies – a description of a clinical event concerning one or a few patients where all procedures were part of the clinical process – no ethical approval needs to be sought. Case studies are however not admissible as papers in a doctoral thesis at Karolinska Institutet, since they are not scientific research studies. However, if paper I instead of a case study is considered to be a research study of one person, which might be a more reasonable interpretation, it can not be conducted without ethical approval. Paper II also has no ethical approval [my comment: paper II is also published and can be found here]. In the article it is said to be a case study but both studies include interventions that are not usually part of clinical treatments. This is especially clear in paper II, which studies the effect of nicotine (via e-cigarette) on current pharmaceutical treatment. It probably constitutes a drug trial but the committee does not take a position in that question. We do however consider it clear without a doubt that the study requires an ethical approval in accordance with the Ethical Review Act. Only one of the remaining studies (papers III and IV) is published [my comment: paper III can be found here]. The rules of Karolinska Institutet require doctoral theses to consist of at least two papers that are published or accepted for publication. This review therefore results in a rejection of Sara Riggare’s application to defend her doctoral thesis.
Some thoughts on the subject
Of course I am disappointed at having to postpone my doctoral thesis defence and even though I don’t agree with the Dissertation board’s interpretation of the rules, I accept their decision. I completely understand that due to recent events, they feel the need to be cautious when it comes to ethical issues.
The reactions and comments I had on Twitter and Facebook clearly demonstrated that the questions of ethical review (or not) of self-tracking activities is of international interest. One of my friends even wrote a very eloquent blog post on the topic (link here).
As you can imagine, I have been thinking a lot on these issues for the last few days and the whole situation to me further reinforces the feeling that we live in interesting times. We must all accept that the world around us is not static and that in our world of increasingly raplex (a combination of ‘rapid’ and ‘complex’, said to be coined by Peter Berger) changes, rules and regulations that were appropriate for a world without Internet, smart phones, and social media, are no longer fit for purpose. I want to list a few issues specific to my case that I think demonstrates that.
What is a research study?
The Swedish Ethical Review Act defines research as: “scientifically experimental or theoretical work intended to result in new knowledge and development outcomes on a scientific basis, excluding work that is performed within the framework of higher education on the basic or advanced level” (translations taken from here). Worth noting is that the definition does not explicitly include intent to publish the results from the ‘scientifically experimental or theoretical work’ in the form of peer-reviewed articles. The Act further states that it applies to research that includes handling of:
Section 3
This law shall apply to research that includes the handling of: 1. Sensitive personal data pursuant to Section 13 of the Personal Data Act (1998:204), or 2. Personal data regarding violations of law that include crimes, judgments in criminal cases, penal law sanctions, or administrative deprivation of liberty, as defined in Section 21 of the Personal Data Act Law (2008:192).
Section 4
In addition to that which follows from Section 3, the law shall apply to research that: 1. Subjects a research subject to a physical intervention, 2. Is performed according to a method with the purpose of affecting a research person physically or mentally, includes an apparent risk of injuring the research subject either physically or mentally 3. Relates to studies of biological material that has been taken from a living person, and can be traced to that person 4. Constitutes a physical intervention on a deceased person, or 5. Relates to studies of biological material that has been taken from a deceased person for medical purposes, and can be traced to that person. Law (2008:192) 3 and 4§ The Swedish Ethical Review Act (translations from https://www.epn.se/media/2348/the_ethical_review_act.pdf )
My paper II (link here) reports on a study where I used a finger tapping app on my smart phone to evaluate if and how the response of my Parkinson’s medications varied over the course of the day. I did not administer any physical intervention on myself, as far as I am aware, I did not intend to affect myself physically or mentally (if not learning more about your own disease and how to better manage it can be considered a physical or mental effect).
Is it reasonable to say that such a study falls under the regulations of the Ethical Review Act?
Where is a research study conducted?
5§ of the Ethical Review Act states that the act applies to research conducted in Sweden. The data collection for my paper II (link here) was not conducted in Sweden. Does this mean that the Dissertation Committee was wrong to dismiss that paper? I don’t know and that is not what is important here. The important thing is that the regulations are not appropriate for the world we live in. For another study, I collected finger tapping data during a flight between Sweden and the US. In what country should I have applied for ethical approval for data collected in international airspace? It is clear that we need to update the regulations to the global and connected present day that we all navigate.
Who can be a researcher?
The Ethical Review Act does not offer any definition for this. It does however define responsible research body as:
A government authority or a physical or legal entity under whose auspices the research is conducted
[2§ The Swedish Ethical Review Act (translations taken from here)]
The Act further states that:
Research subject: A living person who is the subject of research
[2§ The Swedish Ethical Review Act (translations taken from here)]
The research may only be approved if it is to be conducted by or under the supervision of a researcher who has the necessary scientific competence.
[11§ The Swedish Ethical Review Act (translations taken from here)]
In my case the research subject and the researcher are one and the same. Does this mean that every citizen scientist and self-tracker in Sweden needs to apply for ethical approval for every experiment they conduct on themselves if they want to be able to publish their findings (even though publication is not explicitly part of the definition of research)? Or should the Act be interpreted even stricter? It is widely acknowledged that managing the complex treatment regimens of type 1 diabetes takes a lot of knowledge and competence. And that many people living with complex chronic conditions in time know more about their disease than their physicians do. Does that mean that people with for example type 1 diabetes should be considered researchers? And that everyone in Sweden with type 1 diabetes needs to apply for ethical approval for every time they measure their blood glucose level and draw new conclusions that they apply to their insulin dosing?
Conclusion
Of course we as a society need to ensure that all medical research is conducted in an ethical manner. We also have a collective responsibility to ensure that our rules and regulations are appropriate for the day and age we live in. I hope that my case can lead to a thoughtful discussion on how regulations for medical research should be formulated and implemented to ensure ethical aspects while at the same time not stifling innovation and progress. Such an outcome would totally be worth postponing my doctoral dissertation for!
What happens next?
Sara, thank you for explaining and enlighten us all on the circumstances leading to the postponing of your defence of your thesis. We are in no doubt that you will reach your goal and we will support you as far as possible and as much as needed for you to succeed. Good luck, mom
Hi Sara!
We do not know eachother, but after listening to Vårdmaktpodden with you I read this about postponing your defence of your thesis due to the ethical decision by the Dissertation Committee.
I think that you are, in your way of thinking about and conducting research, many years ahead of a system that is constructed for another kind of world.
Please let med know if we can do something to support You.
Sincerely yours
Rebecca Engelbert
Leg. Psykolog & Verksamhetschef at Medisera
It’s a horrible and strikingly infuriating situation for you, one that seems particularly arbitrary. I wanted to comment because I am struck “academically” by cross-country (US versus Sweden) Human Subjects Protection rules/text and interpretation. Since some of my research is epidemiological and specifically go out (not personally!) into the community to identify people who have a health condition but have never been diagnosed and treated for it, participants are NOT patients at all from my US university’s perspective, but Human Subjects Protection review rules apply just as if they were patients. The review is conducted by our IRB (as you know, Institutional Review Board). At my prior university, I chaired an IRB committee.
Most critically, in the US, “Research” is defined as ‘systematic collection of data for the generation of generalizable knowledge” (my brain’s reconstruction of the precise wording but all key concepts are present). Again, nothing about intent to publish. But the concept of Generalizability is key, so that IRB review would be excluded, for example, for data collection designed to evaluate the efficacy of a specific, program. Evaluation research is excluded from IRB review. Similarly, the concept of generalizability is critical, since it make it clear that individuals with Diabetes monitoring their own blood glucose levels are not systematically collecting data to generate GENERALIZABLE knowledge, even if they submit (by their own hand) to a physical intervention.
But what I am not totally clear about is whether your self-monitoring study was intended to generate generalizable knowledge. From what you have written, it seems more like demonstration of a method that other patients could use for their own self-monitoring and is explicitly not intended to be generalizable. One could argue that the published study was published because it demonstrated the utility of a self-tracking method. Is demonstration of the utility of a self-monitoring method generalizable? In fact, your self-tracking method would not be useful for me, because my PD symptoms are no longer motor (which I attribute to exercise) but I still experience significant nonmotor symptoms. Thus, I do not believe that an IRB in the US would view your paper as an instance of Human Subjects Research requiring IRB review.
The ‘generalizable knowledge’ definition of research comes from the US Dept of Health and Human Services Office for Human Research Protection 46.102, Subpart A, otherwise known as “The Common Rule.” Unfortunately for you, what a difference the definition of “research” makes!
“Raplex” reminds me of VUCA (volatile, uncertain, complex and ambiguous), a term used by management consultants in recent years. A 2020 episode on the Soonish podcast by friend Wade Roush hosted Jamais Cascio of IFTF (Institute For The Future), who proposes taking that to the next level: BANI – brittle (vs volatile), anxious (a step beyond uncertain), non-linear (worse than complex), and incomprehensible (beyond ambiguous).
At first I rolled my eyes at futurists’ need to always be a step ahead, but as I thought about it, it seems genuine – at least worth thinking about. So many rules of the game are changing rapidly and without notice that we *constantly* need to be ready for any unexpected new “laws of nature.”
Of direct relevance to your post (and what’s happened in the 3.5 years since) is the paradigm shift regarding who is qualified to identify and pursue a research question.
Here’s that episode of Soonish https://www.soonishpodcast.org/401-bani