Safety of Patient Partners in SPOR projects

I haven't written in a while and want to get your feedback on a situation of concern:

There are so many digital narratives being created to raise awareness of what it is like to have a particular health condition. These are great: the public learns and interest and support grows for research funding and improving the delivery of healthcare.

I was recently recruited to create a 2-4 minute digital narrative by a SPOR/University research collaboration. We patients with a particular type of health condition were to create a digital video story about our illness and how it impacts our life. So, this is okay.

But...there will not be any contract signed or in writing stating who owns these digital video narratives, where they are stored, or what limits their use or broadcasting. There are only verbal assurances that it is a 'living contract' that the video narratives will only be used with the creator's permission and/or the patient who created the video can have it taken down after posting.

I am not satisfied with this at all! these video narratives detail the most intimate personal medical information, and may include family and friends in them as well.

With no written contract, this leaves the patients who create these narratives for the benefit of the research program, with no protection or recourse if anything untoward arises. I'm thinking denial of insurance claims or coverage if seen by an insurance provider; or employment opportunities lost if seen by a potential employer; of family or friends or their relationships/trust with them being harmed, from unwanted publicity or portrayal in the video.

What feedback or suggestions do you have? is this a red flag for anyone else? I hate to see patient advisor/patient research partnerships become a cause for harm to the patients.
Thank you...Susan Katz

To me it's an ethical issue as well as a safety issue. It's hard to see that part of a project as part of a research partnership, when one part of the partnership is exposed and there are no boundaries.
I have been recorded talking about my health issues but not for widespread use, and not with much emotion. So many want a big emotional impact like the Ignite talks at the Medicine X Conference. When I still worked full time I was even more careful about exposure, as you and Toby mention.

I agree. it is an ethical issue. How can they ask you to participate in something when they won't give you all the information you need to feel safe and won't put anything in writing?
It makes me think that, if there isn't anything already, we should come up with some guidelines around privacy and consent to help patient partners protect themselves in these types of situations.
Is this considered a research project that went through an REB? Otherwise, am I missing something to understand why SPOR is involved?

Hi Annette,
It is certainly also an ethics violation as well as a personal safety issue, when partnering in healthcare research and sharing personal medical information.
I sent this group a message that I am quitting their project, and cited the Personal Information Protection and Electronic Documents Actthat they are destroy any documents and are denied permission to share any of my personal information.

There was a time when patients were included as expert voices in healthcare decision-making and research.
Now, control seems to be once again in the hands of the institutions, and being a 'patient partner' can be a hazardous endeavour.
Then there are the whistle-blowers like me who want to know where the contract is...
Thank you for your input, it is quite validating and empowering.
...Susan

Hi Kathleen,
I have been greeted with silence when asking the questions you are posing. In fact, two people cc'd by the SPOR partner in her message saying I could quit if I don't like the situation, are unknown to me and did not respond to my email to them.

According to LinkedIn, they are: --a Senior Research Associate, Department of Community Health Sciences and: --Associate Professor, Patient and Family- centred Care Scientist, Provincial Lead, Patient Engagement SPOR.
It is a University Research/SPOR collaboration, and the person facilitating the digital story telling workshops is a patient partner.

One reason I am posting to PAN, is in the hope for some action, as you suggest, to "come up with some guidelines around privacy and consent to help patient partners protect themselves in these types of situations". PAN seems to be the place where patient advisors can create guidelines for patient participation in healthcare-related research and decision-making.

Best...Susan

Hi Susan;
I agree with you that once something/anything is posted to the internet (or even to a 'secure' intranet), it is in the 'public domain'... and to use an expression which I coined many years ago:
"A verbal contract is not worth the paper it's not written on".

IOW when I am asked to complete surveys or submit other things that may contain any of my personal/financial or other potentially sensitive information, I generally first ask what are your policies regarding a) privacy & access to such information, b) your on-site/in-house physical security of my information (hardcopy or electronic), c) archive policy for disposal of my document(s) when no longer needed/used for the original purposes, d) for the most recent report(s) on their security (containing any information on their past year's performance -- including any data security breaches -- and how those were handled/rectified/or...?) and finally, e) may I please see each of your verbally-described (or words in your preamble/solicitation overview) safeguards as formally incorporated showing authorization(s) by whomever is heading the organization (and/or by its internal oversight "watchdog" functionary eg. the internal audit committee -- if that exists -- and their reporting to the governance officials). It is also appropriate to ask the "what if" question ie. what if there is a breakdown?... what are the recourses for me and you to remediate such events?
You are right to ask those kinds of questions -- not just for the potential risks you have described, but for the "unforeseen unforeseens"! The organization will need a very robust level of assurance -- policy and practices -- before I would divulge certain of my information.
Bonne Chance!

Yes, agreed!
Certainly, I know where I stand on this and will drop out.
It worries me that the other nine participants are not asking any questions, though, and are giving away their personal information with the encouragement that they are 'helping others'.

If there are a few people who want to get together to discuss this further I would be glad to be part of that group (my background is in ethics). There may be situations that are under the radar that people are wondering about and that would be helped by some guidance document. Meanwhile, I will do some research to see if there is something out there already that would help.

Hi Susan and everyone,

This is a very important topic you bring up and I too would love to see something possibly formalized within SPOR or some guidelines that could be used to help bring awareness that can be promoted across the research community... not just those funded by SPOR.

As a patient partner, I don't have the capacity to help put something together in the next while, but I could help move it up the chain and get it into meeting discussions and to some key individuals to start thinking about it and moving this forward in some way (I'm on the Board with the Ontario SPOR Support Unit and like some of you have solid linkages with CIHR).

I'll stay posted on anything that might move forward over here.

Here is a CIHR document for developing research partnerships with patients. Maybe people have already seen this. If it doesn't address your specific concerns that would be a starting point to develop something else.
https://cihr-irsc.gc.ca/e/51910.html#2

I am jumping in not because I have run into this personally but because this seems like a critical safety and ethics issue for patient partners. I have run into the request for patient videos some years back where the intent seemed to be mostly to showcase the organization and their "patient-centredness". The participants were left with a bad taste in their mouths. Also, this org was merged into another entity so no telling what has happened to the videos.

I agree that this should be something that we can come up with guidelines on at a minimum for our Community. This could then hopefully lead to SPOR and other orgs picking up the guidelines. At least we could have a tool for patient partners to ask questions.

I am going to suggest that those interested in exploring the development of PAN Guidelines for patient partners on this contact me directly by the PAN email hello@patientadvisors.ca and I will set up an exploratory meeting. Based on the great feedback above, I doubt it would take that long to develop. Once we have it, we can post it internally but also Tweet it out to our colleagues who are not members yet.

Thank you all for jumping in on this.
I will write to you Alies and look forward to addressing this more formally.
All Best...Susan

Intellectual property while engaged as a patient partner in research is a very important issue and most of us a very naive to the ethics and legalities as well as copyright rights, control of information and ideas, and privacy. Px need to be able to have access to legal advice.

Thank yo so much Susan.
I am in a particular (weird) situation, unsure how to handle it. Your letter has provided validation and guidance in the direction I want to go in.

POR Patient Orientated Research. This is anything but patient orientated. It is by and for the researchers with no patient protection. They may have excellent ethics and intentions to protect the patient's information but without written and signed guarantees there is no real protection for the patient.

I heard back from one of the directors of this project, with his explanation of how they do things. I won't share the entire message here, but one line seems to summarize why there has been no release or consent form provided:
"Asking for permission to share the stories before the stories are created can be awkward if people feel like they want to change their mind about the release at the end based on the story they eventually create, and we want people to feel as comfortable as possible."

I replied that if it were all in writing ahead of time, people would know what to expect and adjust their sharing accordingly.
I also wrote that changing one's mind is a right that patients have with regard to sharing healthcare information; we can withdraw consent.
This reminds me of one of those projects that Alies describes, to showcase the need to fund certain types of research; and I certainly have a bad taste in my mouth.
We don't have to agree to the video being used this way; but with no consent forms up front, and the videos being stored in the provider's account unless a participant knows to ask to have theirs removed...
...Susan

Thanks Susan,
Love the gobbledy gook " want people to feel as comfortable as possible".
Have seen this type of explanation before. Very weird, very patriarchal, IMO.

Susan- Appreciate you raising this question and sparking an insightful conversation thread. I suspect there are others who have felt the same discomfort , yet parked it aside for fear of being labelled as difficult or they believe this is the way it is , since others are accepting the terms. As well, some may not be thinking through the potential implications . I agree that it is an ethics -value issue , and glad to see PAN members stepping up. Our collective voice has more influence than a single one .TY

Yes, it will be nice to create guidelines and standards of ethics for engagement with patient advisors, for many reasons. Glad to hear that having a lack of paperwork/ethical guidelines is a situation others have experienced as well, and are ready to improve upon!

Hi Susan and all,
I've been following this discussion with interest. I find it unconscionable that the researchers don't collect this data (the videos) with a consent PRECISELY BECAUSE the participants might actually exercise their rights to control access to their personal contribution at this or a future time.

Your examples of harm are real. But also, I think these folks have violated any usual ethics for the project and copyright on the videos. Before PAN creates its own code of ethics for advocacy, it might be better to consider first (1) how a patient partner can routinely learn the ethics environment surrounding a study and (2) how a patient partner can safely blow the whistle when ethics are absent or violated systematically as in this project. It could be an individual violation or a collective one, as in this case.

I'm really quite appalled at the conduct here. Members of this team must learn that they cannot treat research participants as product/data/testament generators with no accountability on control of use and storage limitations. I wonder if they even applied for Research Ethics Board approval in advance? Sounds like it's a miss.

The awkward thing, of course, is putting whistle-blower duty on our shoulders, usually sitting at the low end of the power gradient. You, Susan, quit the project with stated reasons, but I wonder about the vulnerability of other participants in this and future projects with the members of this team. The coercive need to play "the compliant patient" to safeguard vital care relationships is vivid for many people. It isn't easy to shake this deference when moving from clinical care to research participant. Many of us have expressed in one way or another, what a privilege it is to contribute to better healthcare. That willingness must not be abused.

And when all is said and done, the junior researchers here are learning "how to do it" from the Principal Investigator. I think this avoidance of ethics is shameful and abusive.

Thanks for posting on this topic. I'm steaming mad and motivated to rattle the cage.

Safety of Patient Partners in SPOR projects 14 36 93

Safety of Patient Partners in SPOR projects

14

36

93