Requesting informed consent documents

Wikipedia could be used as a channel for conducting and managing information requests. This has not been done previously. I would like for it to be done in the future. This post is three of three in a series, and this one talks about Wikipedia and information requests. In other posts I describe MuckRock as a model for comparison to Wikipedia and the idea of using Wikipedia as a channel for making information requests.

In this post I have one big idea – that informed consent documents for clinical trials to be available online for the public. This is not controversial because no one thinks about this and the idea would strike almost anyone as odd, because the request itself asserts that these documents are not public and should be. People who do not know these documents exist would not know what to think of such a request, and probably the traditional view of the entities which hold these documents is that they are already public and should not be. There is misconception and lack of attention on this issue, and I myself am unusual for talking about this at all. So far as I know, no one else cares at all.

I want this because informed consent documents are the layman explanations of a clinical trial which are intended for public consultation, and if these documents cannot be brought by participants into public forums for discussion, then their ability to give informed consent is lessened. As an example of what I think this would enable, it could permit a person enrolling in a clinical trial to share the informed consent document with their friends and talk among them about the trial, just as they might do with other health concerns. Right now, there are restrictions which discourage research participants from doing this.

The informed consent document sharing could happen with or without Wikipedia, but since I feel that Wikipedia offers several unrelated sets of benefits to doing this and that any of those benefits could be used independently of any others, I am writing from the perspective that the documents should be free and they should be on Wikipedia. If they are free in any form, then they could also be mirrored on Wikipedia, so in any case Wikipedia could have some role in this.

Researchers could have a lot of objections to the sharing of these documents. Most of their objections would have nothing to do with patient safety, and in any case, the system of secrecy has some major financial motivations which present a financial conflict of interest which impedes any researcher’s ability to think clearly about this issue. Whatever objections may exist, the strongest argument for sharing these documents is that any one community stakeholder of a clinical trial has a right to have oversight on the clinical research happening to people in their community, and no other arguments preclude anyone else’s rights to discuss this public information. If there is no available layman information available to peruse, then the right to oversight is blocked. This right to oversight was called “respect for persons” in the United States treatise called the ”Belmont Report”, and has always been fundamental to research. This right is newly relevant now, because for the first time, online communication is part of many people’s lives and the informed consent process needs to change to acknowledge the advent of the Internet.

Some people may argue that the information I want is not or should not be public, but from my perspective, a confirmation from the copyright holders that they do not want this information to be public would be extremely useful also. There is no bad outcome to making this request.

About this post

I am writing this post for a range of audiences which include Wikipedians, participants in the open movement, persons interested in online health information, and persons interested in clinical research. This proposal is a convergence of the interests of these groups, and since these groups do not themselves have much natural overlap in interests and background understanding, I am going to give information which would give the context and perspective of each of these to the others. I encourage readers to skip around if something seems too simple, because I present some basics here. While nothing I say here is too complicated, I expect that among other things, medical researchers would have little understanding of how online media rights affect unmoderated discussions among strangers on the Internet, and media rights advocates may not immediately gather that informed consent documents are intended for public viewing as they have been copyrighted and shared privately (only for lack of sharing technology, so I argue) for decades.

The problem: It is not possible to discuss clinical research in a human way and it should be

The problem which this proposal addresses is the removal of the artificial barrier which research participants have in discussing their participation in clinical trials with the people in their social communication circles who help them make health decisions. A familiar analogy is that when someone has a serious health problem for which treatment will not guarantee a favorable outcome, their physician may offer them a range of choices for addressing their health concern. For example, the physician may present a patient with the difficult choice of choosing between a stressful medical treatment without promise of positive result or declining treatment and continuing to bear the medical problem, but not having to endure the treatment. in this case, the physician will strongly recommend that the patient consult with their family and friends before making a decision. In a similar way, persons who volunteer for clinical research should be able to discuss their participation in that research with the people who help them make decisions, and right now, it is not possible for people to talk about their research participation in a normal human way through the normal communication channels which humans use. The informed consent process is designed for conversation in the context of inhuman organizational oversight and with moderation by an organizational protocol, and although this has benefits, these current research practices have not been revised since the advent of the Internet, and I would like aspects of the research process involving ICDs to be revised to acknowledge Internet communication. I would like for people to be able to discuss clinical research online, such as on any kind of website including forums, blogs, Facebook Twitter, email, or any other online service which people use, but researchers currently prevent this by inappropriately using copyright protection to restrict the way that people can discuss what published information about clinical research exists for layman use and discussion. I would like for stakeholders in any given clinical trial to be able to discuss that trial while having free access to the informed consent document, which is the layman document which exists only for the purpose of explaining the trial to the public. Because these documents are copyrighted and withheld from the public, the public is harmed and is disempowered from understanding the implications and impact of clinical research. I am demanding that these documents be made available for people to read, redistribute, remix (such as with annotations, questions, and emphasis), and discuss, even when their discussions are not moderated by the entities conducting the research.

Statement of the request to clinical researchers
Suppose that you are a clinical researcher managing a clinical trial, and suppose that you are recruiting research participants from a certain community. A member of this community contacts you and asks you these things. How do you respond? I follow the questions with the answers I anticipate based on having received them lots of times.

• Can I make an appointment to ask you some questions about your clinical trial?
• I expect that any researcher would answer such questions and be grateful for the community interest.
• I seem to be a suitable candidate for your clinical trial. May I have a copy of your informed consent document?
• This question is currently the only route by means of which researchers would expect anyone to want or receive an informed consent document. The more usual case is that the potential research participant does not even want the document, but the researcher gives it to potential research participants during recruitment.
• Can I, a non-participant in your trial but a member of the community of trial participants, have a copy of the informed consent document for your clinical trial?
• I expect that any researcher would share this document, but public distribution of the informed consent document in this way would be memorably odd, and might only happen every few years to anyone working in the field. Still, anyone has a right to see the document, and a request like this would not be refused.
• Can I have a copy of the informed consent document for your clinical trial, and will you grant me a license to republish and remix this document so that I can discuss it with others online?
• I expect that any researcher would stop here and pass the request to others, who in turn would not know how to respond. The soft answer would be dissuasion, the next answer would be that harm would come to everyone if this happens, but I think that the hard answer is that the information is for the community to share and discuss and not for the researchers to withhold against community will.

Here is an example letter template that I would send to researchers.

Note that once the community makes the request to researchers, all possible outcomes are excellent for the community. Any of these may happen:

• The researcher provides informed consent documents, and the community has more access to information.
• The researcher declines the request, and then the community for the first time has explicit notice that this information is not available. The expectation that the information is available for public consultation is dispelled, and the relationship between researchers and the communities from which they recruit participants is changed just because of the new observation.
• The researcher declines to answer the request, in which case all clinical trials conducted by the information withholding entity are in tension in a way which favors the rights of research participants. If I were a researcher, and I ever had any problem with a clinical trial for which the public had previously requested basic layman transparency, then I would not want to deal with my own past refusal to be transparent.

The place of the informed consent document in clinical research

Clinical research is health related research done with human volunteers as test subjects. These human volunteers are termed “research participants”, and any given instance of clinical research is called a “clinical trial”. Each clinical trial is managed by a researcher or researcher coordinator, with this person being a human (and not an organizational entity, for example) who does things including recruiting research participants and executing the study protocol. The “study protocol” is the manual which gives specifications for executing the clinical trial. “Recruitment” is the process by means of which a research coordinator requests a potential research participant to agree to participate in the informed consent process which would signify their entry into the trial. The informed consent process is an event during which the researcher and a potential research participant meet and discuss the trial with the expectation that if the research participant is willing to join the trial, is a suitable candidate, and can provide their informed consent to participate, then the researcher will invite the potential research participant to volunteer to enroll in the trial as a research participant. If a research participant provides their informed consent to enroll in a trial during the informed consent process, then that participant enrolls. Somewhere at the beginning of the informed consent process and definitely before a potential research participant can enroll in a clinical trial, the research coordinator will give the potential research participant a copy of the informed consent document (ICD). The ICD is a text, almost always published on paper, which contains certain text presented in a standardized way, and is necessary to the informed consent process but simultaneously – and this is the strange part that I am seeking to probe – somehow not containing any information which the public needs to have in the sense that practically all clinical researchers would hesitate to make this document too easily available for many people to read.

Lane’s premises about sharing the informed consent document – check Lane’s medical research sensibility here

What follows is a list of the premises which I hold about clinical research and which lead to my thinking in the way that I do. I present them here so that anyone can challenge them before reading too deeply in the rest of my idea, and because while I expect that others would accept my premises I also feel that I making an odd proposal outside of popular thought, and I want anyone to have access to the fundamentals from which I draw my conclusion.

1. Clinical researchers are bound by ethical duty and law to share some minimal amount of information about their research with the volunteers who agree to be research participants.
2. The informed consent document for a given trial contains the minimal amount of published information which the researchers see fit to share with research participants in its attempt to conduct the informed consent process.
• No one would say that the informed consent document contains the minimum amount of information which researchers should share with participants, but it holds a unique place as the published information which passes from researcher to participant. Participants can request more verbal off-the-record information, but it would be exceptionally unusual and require complicated bureaucratic oversight to give research participants additional written information.
• Additional information of major significance to study participation is shared outside the context of the informed consent document, and the usual case is that no information whatsoever about is presented in addition to the information contained in the informed consent document. If information is recognized as necessary to constitute informed consent then it is in the informed consent document.
• Note that for various reasons, clinical researchers are not prepared to describe their informed consent documents as being “the minimal amount of published information…” and they would say that such a minimum does not exist, and that the informed consent document ought not be available outside the guidance and oversight of their appointed staff. They do not like these documents to be read by the public.
3. Participation in clinical research has benefits and risks. There is a concept in clinical research called “justice” which says that benefits and risks of clinical research should be fairly distributed.
4. The informed consent process and the conduct of clinical research is not only a private act between a researcher and a research participant, but it is also a community process wherein any community which provides volunteer research participants also has a right to have oversight over the clinical research which affects its members.
5. Communities have oversight on the clinical research for which their members volunteer, because communities share in the burden of the risks to which volunteers subject themselves by participating.
6. Right now, there is no particular communication channel for interested members of the community to have oversight over any clinical research happening in their community.

The nuance here is that there has been a cultural shift in expectations for communication since the advent of the Internet. People increasing expect public information relevant to their well-being to be available to them in a useful way.
The useful kind of oversight which communities would want but lack is the ability to participate

Harms of sharing the ICD
Undoubtedly, public access to ICDs would cause research harms, public health harms, and harm to individual research participants. I personally find these harms to be minimal and within the duty of the research coordinator to ameliorate, but I will comment a bit here.

Layman who read informed consent documents will not understand them outside the context of an in-person explanation from the researcher. This is true in many cases, but it is also true that researchers in partnership with something called an “institutional review board” do every reasonable thing in their power to make the documents as comprehensible as possible. Among other things, the documents are typically written in simple English (sometimes called international English, plain English, low-literacy English, or 6-8th grade level English), and everyone purports that the informed consent document is a necessary part of the informed consent process. All trial participants receive a paper copy of the informed consent document upon joining the trial, and they can already do as they like with this document, so long as they do not violate the copyright protecting it. This means that they discuss it with others in person, but not online.

If informed consent documents are shared then the public will come to know what research is happening where, and this will radically and fundamentally change the nature of clinical research because right now it has huge financial dependence on being able to conduct research on human volunteers in secrecy. This is also true, but this is an unrelated issue taken up by other activists who are doing other things. There is a movement called AllTrials, for example, which wants “all trials registered, all reported reported”. AllTrials is a great cause, I hope they achieve their aim, but they do nothing to directly benefit research participants and communities because even if all trials were registered and results were reported, that still would not free any layman explanation of what the trials mean. The informed consent document is the only media within clinical research which attempts to do this. Incidentally, I feel that AllTrials is overly science focused.

The greatest counterargument to avoiding harms and continuing the restriction of access to informed consent documents is that any one individual has a right to publicly discuss clinical trials in their community. That harm could come to others does not prevent others from having the right to exercise their own rights, especially when the harms which exist are solidly within the power of research coordinators to address and the benefits to participants for sharing the documents are great.

Read more
Again, my only idea is that information associated with clinical trials should be clearly designated as being for the public or not for the public, and that the information which is for the public should actually be accessible by the public.

I have another manifesto of this on Wikimedia Commons as ”Visualize Everything”. I also have something in Wikipedia workspace as WikiProject Clinical Trials. I am always ready to talk about this with anyone who feels passionate about participant rights in clinical trials.

Prototype
Most clinical trials do not meet Wikipedia’s inclusion criteria for discussion, so although Wikipedia would have some part in explaining the concept of clinical trials and connecting informed consent documents to the media archive listings for Wikipedia articles about research entities, this project would not lead to the creation of Wikipedia articles for most trials. Sometimes it would. I made a Wikipedia article for the PARAMOUNT trial because I was able to get an informed consent document for it.