I learned through a simple ethic training, that consent forms where created following World war II, to prevent the horrible things that happened to all those who where abused and tortured into research.
As a patient who participated in many research, consent forms where Chinese to me, and felt like an insurance contract where you feel like there’s a trap somewhere.
Later on, as I became patient partner in research, it became clear to me that consent forms where to protect institutions. And as I started guettons involved in research teams, it is the first issue I got involved in: making consent forms intelligible, getting people to understand to what they are contributing; because isn’t it what we all seek for? Contribute to actions that make sense?
So yes to all you’re saying. Surely ethic boards have to be less bureaucratic, and work closer with the research community INCLUDING patient partners in research, because without on boarding patients as true partners, collectively we are loosing a perspective that IS uselful to ethics.
I would be curious to dig into what those REB recommendations look like and how they could be improved.
Since my background is in project management, we have a concept called change request that is specifically designed to manage changes that a client, internal team, or anyone requests.
This process is relatively formalized in some teams where you can't simply request a change verbally or by email; you have to put it on paper and explicit how each request (one by one) will impact the goal triangle (scope, time, resources... and sometimes the political context). Some project managers won't even accept a halfway-done change request.
Why? Because what is simple for someone can be complex for someone else (complexity management).
Hence, it cost me almost nothing to make a series of change requests...
But someone will have to spend a lot of resources to implement them.
To this effect, a change management form (or ticket) usually forces the party that requests the change to consider the consequences of their demands. Maybe, after all, they will recognize that some of those requests are nice to have but do not worth the 20 hours worth of work involved in applying them vs. other priorities.
A change request document can be as simple as a one-pager (with a field for priority level, cost impact, scope impact, timeline impact, and such). Still, it can be tremendously efficient to set realistic expectations and put everyone on the same page, literally.
An excellent point! What you describe is part of the problem experienced by researchers where there are more and more information to provide, more forms, and this cost is imposed by regulators but born both by researchers who produce it and the REB members who then have to evaluate it... so there's a disconnect between the actor imposing the requirement and those who have to fulfill these requirements.
I learned through a simple ethic training, that consent forms where created following World war II, to prevent the horrible things that happened to all those who where abused and tortured into research.
As a patient who participated in many research, consent forms where Chinese to me, and felt like an insurance contract where you feel like there’s a trap somewhere.
Later on, as I became patient partner in research, it became clear to me that consent forms where to protect institutions. And as I started guettons involved in research teams, it is the first issue I got involved in: making consent forms intelligible, getting people to understand to what they are contributing; because isn’t it what we all seek for? Contribute to actions that make sense?
So yes to all you’re saying. Surely ethic boards have to be less bureaucratic, and work closer with the research community INCLUDING patient partners in research, because without on boarding patients as true partners, collectively we are loosing a perspective that IS uselful to ethics.
I would be curious to dig into what those REB recommendations look like and how they could be improved.
Since my background is in project management, we have a concept called change request that is specifically designed to manage changes that a client, internal team, or anyone requests.
This process is relatively formalized in some teams where you can't simply request a change verbally or by email; you have to put it on paper and explicit how each request (one by one) will impact the goal triangle (scope, time, resources... and sometimes the political context). Some project managers won't even accept a halfway-done change request.
Why? Because what is simple for someone can be complex for someone else (complexity management).
Hence, it cost me almost nothing to make a series of change requests...
But someone will have to spend a lot of resources to implement them.
To this effect, a change management form (or ticket) usually forces the party that requests the change to consider the consequences of their demands. Maybe, after all, they will recognize that some of those requests are nice to have but do not worth the 20 hours worth of work involved in applying them vs. other priorities.
A change request document can be as simple as a one-pager (with a field for priority level, cost impact, scope impact, timeline impact, and such). Still, it can be tremendously efficient to set realistic expectations and put everyone on the same page, literally.
An excellent point! What you describe is part of the problem experienced by researchers where there are more and more information to provide, more forms, and this cost is imposed by regulators but born both by researchers who produce it and the REB members who then have to evaluate it... so there's a disconnect between the actor imposing the requirement and those who have to fulfill these requirements.