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Posted by on Jan 5, 2019 in Bioethics, CRPS / RSD | 0 comments

Pressure, or not (05.01.2019)

Pressure, or not (05.01.2019)

Back in October, I experienced something of a role reversal. After years managing a Research Ethics Board (REB), I was asked to consider participating in a clinical trial – as a patient. A research participant.

If you’re in the US, a REB is the equivalent of an IRB; an Institutional Review Board. Whether it’s called an IRB or a REB, the purpose of these Boards is to protect research participants – the people who volunteer to take part in research.

Canada’s 3 principal governmental research funding agencies define human research participants (“participants” for short) as:

“those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.

Human participants are unique among the many parties involved in research, because they bear the primary risks of the research.

These individuals are often referred to as “research subjects.” This Policy prefers the term “participant” because it better reflects the spirit behind the core principles: that individuals who choose to participate in research play a more active role than the term “subject” conveys.

As well, it reflects the range of research covered by this Policy, and the varied degree of involvement by participants – including the use of their data or human biological materials – that different types of research offer.

The core principles of this Policy – Respect for Persons, Concern for Welfare, and Justice – help to shape the relationship between researchers and participants.”(1)

There are many subtle differences between Canadian & US regulations governing clinical research, including the definitions used. For example, a different term is used to define a participant in the US research environment:

“Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.” (2)

As another example, there are differences in how REBs and IRBs are defined. In the US, an IRB is:

“any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.”(2)

Canada’s federal research funding agencies, however, define an REB as:

“A body of researchers, community members, and others with specific expertise (e.g. in ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices.”(3)

I have a fairly good grasp of how clinical trials function, and how important they are. So of course I said yes, when asked whether a research coordinator could contact me to discuss an upcoming clinical trial for my rare disease!

When she called, my first question wasn’t about the research protocol; it was on the inclusion & exclusion criteria. To find out whether any of my current medications, or anything in my medical history, would exclude me from participating in the research.

Clinical trial recruiting poster, from McGill University Health Centre (MUHC)

Clinical trial recruiting poster; McGill University Health Centre (MUHC)

After all my years of work in research ethics, I was excited that I might finally have an opportunity to participate in a clinical trial – myself! But one of the exclusion criteria was antihypertensive (blood pressure) medications. I’ve been taking this type of medication prophylactically for a few years, because most women in my family have ended up with hypertension at approximately my age.

That meant I couldn’t participate in this clinical trial. “But,” I thought to myself, “what if I asked my family physician if I could stop taking this medication for a few weeks – or months? That way I could still take part  in the research, and also check whether I could eliminate some of my daily medications… Now that I have so many more prescriptions because of CRPS.”(4)

I explained my idea to the research coordinator, and asked if I could let her know a few weeks later whether I could participate in the study. She agreed, so I made an appointment with my family doctor.

His view was that it would be a good idea to try a few weeks without the antihypertensives, to find out whether I really needed them. As long as I agreed to monitor my blood pressure several times a day, even at work.

My doctor already knew that I have a portable blood pressure monitor at home, and that I’ve been completing symptom diaries – or logs – for a while now ,-) So we set a limit, over which I’d start taking these medications again, and I started my at-home test.

This at-home test went well, so my family physician gave me the go-ahead – from his perspective – to be a research participant in the clinical trial for CRPS.

I just sent a message to the research coordinator, so will wait to hear back from her. Maybe they’ve already recruited all the patients they need, but at least I’ll know that I tried to be part of a research study. To potentially help other people struggling with the same disease

[I’m not getting paid, or any other benefit, to promote this research. I offered to share information about it, because I know how important it is to find viable treatments for patients suffering with CRPS. This blog has always been, and remains, entirely non-commercial.]

two differences blood pressure monitors

Photo: Sandra Woods

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(1) The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2). Chapter 2, Scope and Approach. 12 Oct 2017. Accessed 05 Jan 2019. Web: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter2-chapitre2/

(2) United States Government, Food and Drug Administration, Department of Health and Human Services. Code of Federal Regulations, Title 21, Volume 1 (21CFR56), Chapter 1, Subchapter A – General; Part 56 – Institutional Review Boards; Section 56.102 – Definitions. Rev 01 Apr 2018. Web: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1&subpartNode=21:1.0.1.1.22.1

(3) The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2). Glossary. 10 Jun 2016. Accessed 05 Jan 2019. Web: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/glossary-glossaire/

(4) Complex Regional Pain Syndrome (CRPS) is a mostly invisible neuro-inflammatory & autoimmune disease, which causes horrific pain. Many different types of pain, including neuropathic (nerve) pain and joint pain.

It also causes reduced joint mobility, and range of motion problems, although no one (yet) knows why. That’s a result of the autoimmune component. I’ve written on this blog – repeatedly! – that there are no effective treatments for CRPS. See: It’s CRPS Awareness Day (2017)

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