Wikipedia:WikiProject Clinical Trials

WikiProject Clinical Trials seeks to increase Wikipedia's coverage of clinical trials. The project seeks to develop Wikipedia articles about clinical research and the rights of research participants.

This is a project for developing Wikipedia articles. For the Wikidata project which curates clinical trial records, visit Wikidata:WikiProject Clinical Trials

What is this?

This project is like any other WikiProject in that it seeks to develop Wikipedia articles on a particular topic.

It is unusual because it also supports participants in making requests for published, public documentation to clinics which conduct human subject medical research. There is a document called an "informed consent document" which explains in layman terms the clinical trial and what participation in it means. Volunteers sign this document to indicate their consent to participate. Before the document gets to the volunteer, though, the community in which the researchers are operating have the right to review the document to give comments on whether the experiment is safe and ethical for the researchers to introduce to the community. Historically, it was logistically unfeasible to open the informed consent document review process to everyone, and because of the work burden in even reviewing the document, typically paid staff at an institutional review board would do the review. Now with Wikimedia technology members of this project can request a copy of the document licensed in a Wikimedia-compatible way and upload it to Wikisource. If a given clinical trial otherwise meets Wikipedia's WP:NOTABILITY criteria for inclusion into the encyclopedia, then project members may post a link to the informed consent document from the Wikipedia article covering that trial.

Background

Clinical research, also called human subject research or human experimentation, is scientific research in which volunteers agree to allow a research conduct a health intervention on them. Clinical research always has a practical intent, such as to develop new medical therapies or answer questions which further health research. An example of clinical research would be a doctor in the context of a research trial asking if a person would like to take an experimental drug so that a scientist can measure the effect of the drug on the patient’s body. In such a trial, the person may be a patient who wants to take an experimental new treatment for a disease or more commonly a healthy volunteer who agrees to take a drug for any personal reasons, including a desire to advance health knowledge.

When a person agrees to participate in a clinical trial they must do so according to certain rules which exist to protect the study volunteer. These rules include concepts such as the participant giving their consent to join the trial, and having the right to get sufficient information about the trial to be able to make a thoughtful choice about whether to participate, and to be free to withdraw from the trial at any time. Researchers describe the protections which study participants have during a process called “informed consent”, which is a procedure including a discussion between a participant and a recruiter, an opportunity for the participant to ask questions, the mutual signing of a written agreement which describes the clinical trial, and the opening of a communication channel through which the participate may ask any questions about the trial at any time.

Clinical trials are a critical component of all pharmaceutical and medical intervention research. Many clinical trials themselves meet Wikipedia criteria for notability as at any given contemporary time there are several hundred clinical trials active worldwide which are consuming government, industry, and non-profit budgets totaling USD 100 million over the course of a few years. This vast financial expenditure creates many paper trails including government regulatory announcements, disclosures by any pharmaceutical company providing research drugs or devices, oversight reviews from non-profit organizations, trial reports from the entity actually conducting the trial, and often journalism from the sector which publishes on clinical trials.

Coverage of clinical trials on Wikipedia

As of the end of 2012, Wikipedia’s coverage of clinical trials is scant. Part of the reason for this is that clinical trials, despite often getting coverage in popular media, are difficult to explain and summarize without some technical support from people who understand a given clinical trial. Also it is difficult to identify key sources of information about a given clinical trial without a trial coordinator identifying them because a significant amount of published clinical trial information is not easy to access with Internet search queries in the most popular search engines.

WikiProject Mission

When clinical trials meet Wikipedia inclusion guidelines such as WP:NOTABILITY and WP:VERIFIABILITY, those clinical trials should have Wikipedia articles. This project seeks to prioritize coverage of clinical trials which have the most participants, consume the most funding, are of greatest public interest, and which are likely to be made safer and more empowering to participant rights when a Wikipedia article covers them.

Participants in this project volunteer to increase coverage of clinical trials on Wikipedia and related Wikimedia projects.

Informed Consent Document Collection Project

The Informed Consent Document Collection Project is a subset of WikiProject Clinical Trials which seeks to ask researchers to apply free copyright licenses to informed consent documents, collect informed consent documents which have free licenses, increase public access to those documents by uploading them to Wikimedia Commons and transcribing them to Wikisource, and if the clinical trial is notable to connect the informed consent document to the Wikipedia article on the clinical trial by using interwiki linking.

Background

Informed consent is a process by means of which a study participant learns about a clinical trial and gives their consent to join the experiment as a volunteer participant. One defining aspect of the informed consent process is the mutual signing of the informed consent document by the researcher and the trial participant.

The informed consent document is a study description and agreement which purports to give a potential research participant enough information to be able to make a decision about participating in a particular clinical trial. An agreement follows this description, and if the participant agrees to join the trial, then that person and the researcher would both sign the document, each get a copy of it, then proceed with the trial.

Historically until now, there has been no particular thought about making the informed consent document for clinical trials publicly available. A subset of this WikiProject distinct from the goal of developing Wikipedia articles about clinical trials is the potentially controversial assertion that researchers should share the informed consent documents for clinical trials by applying a free copyright license to these documents so that anyone may publicly share them. With a free license, these documents could be hosted on Wikisource and connected to Wikipedia articles about the clinical trial, among other applications.

Taskforce

The taskforce of the Informed Consent Document Collection Project has the following jobs:

1. Identify and prioritize clinical trials of significance to this WikiProject
2. Identify the contact information of the researchers managing the significant trials
3. Send an open letter to the researchers asking them to apply a free copyright license to their informed consent document
4. Report in this projectspace what response the researchers have to the request
   1. If the researchers apply a free license to the informed consent document
      1. collect it and upload it to Wikimedia Commons and transcribe it to Wikisource
      2. Connect the uploaded file to the Wikipedia article on the trial if trial meets Wikipedia notability criteria
   2. If the researchers deny or fail to respond to the request
      1. Report their response here in this project so that people here can improve the request process to meet researcher concerns
      2. If the trial meets Wikipedia notability criteria, post on the talk page of the Wikipedia article on the trial that researchers have declined to share the informed consent document
5. inform researchers about where they can read in this projectspace, on Wikipedia, and in Wikisource what you have done as a result of their response to this project’s request

Sample request letter

Hello!

I am a community volunteer representing WikiProject Clinical Trials, a volunteer community project which seeks to increase public access to information about clinical trials by crowdsourcing the reporting of fundamental information necessary for anyone to understand a clinical trial and by creating of freely-licensed summaries of third-party media coverage on the trial. I am interested in collecting information about a clinical trial named ??? which your organization is conducting. I am writing to request the following:

1. Can you please share with me any public information sources which describe your clinical trial? I want to provide these to other project members who will incorporate them into the Wikipedia article about your trial. If you know of any sources published by an independent reviewer then those are most helpful, as Wikipedia prefers to cite information sources which do not have the self-reporting bias of being written by the organization conducting the trial. In any case, I am interested in any sources you think describe the trial.
2. I understand that research participants in your trial sign an “informed consent document” in order for you to allow them to participate in your trial. Would your organization be willing to apply a Wikimedia-compatible license to this document so that the public may share and discuss this document among themselves in the way most natural to their needs? If your informed consent document does not have a restrictive copyright on it, then I would like to share it through Wikisource, the Wikipedia-affiliated document repository, and make it available to anyone who does an Internet search for your clinical trial. If you want to read discussion about our project to collect informed consent documents or give input to this project, you may do so here.
3. This letter is an open letter which has been publicly sent and recorded in the WikiProject Clinical Trials project space here. Your response to this letter will also be recorded in this space, either in summary by a volunteer or verbatim if you will apply a free copyright license to your reply so that we may publish it. When you respond, your letter will be under typical copyright protection, but if you like, you can apply a Wikipedia compatible license such as a Creative Commons license or any other license here if you wish to share it publicly. Would you please explicitly state “My organization applies Creative Commons licence CC-BY-SA 3.0” (or any other Wikimedia compatible-license) in the text of your letter. Until we receive a reply we will note that we have not received your reply.

Thanks for your attention to our project to promote public access to information about clinical trials. If you would like to participate beyond the request we are making in this letter, please check out the open tasks in our project space. We especially need expert input into the information we are sharing about research participant rights because Wikipedia seems to be the world’s most popular source of information on this topic as judged by Internet search return rate.

I look forward to your reply.

Yours,

Frequently asked questions

1. What is the point of this WikiProject?

   This project seeks to increase public access to publicly published and freely-licensed information about clinical trials.

2. Why should the public have access to clinical trials?

   One perspective to answer this question is that public access to information about clinical trials matters to these two populations:

   1. Clinical trial participants need information that they can understand so that they can be better informed when they give informed consent in a clinical trial.
   2. The communities in which clinical trial participants live have a stake in the safety and protection of clinical trial participants in those communities in the same way that they have stake in all aspects of the community’s rights.
3. Why should information on clinical trials be available on Wikipedia?

   Because any given Wikipedia article frequently takes a high rank in search engine queries, Wikipedia is either the world’s most consulted source of information on most topics or it is at least an extremely popular source of information. It seems to serve information in a format which the public desires.

   Aside from being demanded by the public, Wikipedia is also a neutral reporting platform for all existing information. Whereas, for example, a clinical trial coordinator will likely choose to provide information about a clinical trial in the way proscribed by their managing research institution, Wikipedia will only provide information about a clinical trial in the way that communities demand. Wikipedia creates a public, transparent forum where people can talk about making the best possible encyclopedic article on a clinical trial.

4. To what extent can the integrity of a clinical trial ever be harmed by covering it on Wikipedia?

   The standard guidelines for Wikipedia say that all articles on Wikipedia must be backed with citations to information from published reliable sources. Because of this, there will never be information on Wikipedia about any clinical trial which is not published and available for the public anyway. This project does not seek to publish or report any information about a clinical trial which is not already published and available to the public, and because of this, this project cannot do anything other than deliver already available information to people who request it. People who think that this project can harm the integrity of a clinical trial are free to post in the public, permanent, transparent forum of this project’s talk page.

5. Why does this project want informed consent documents?

   Informed consent documents are certain to contain at least the minimal amount of information which a research participant would need to be able to give informed consent to participate in a trial. If the public has access to the informed consent document then the public will have what is - in the researcher's opinion - at least the minimal amount of information required to understand a clinical trial well enough to agree to participate in it, and without access to that document the public will not have that information. Because this project wants the public to have at least minimal information about trials, this project requests the informed consent documents which contain that information.

6. Why do researchers apply restrictive copyright to informed consent documents?

   Many media producers in many fields indiscriminately apply restrictive copyright to everything they produce. This is especially strange in the field of benevolent non-profit educational outreach with no intent to promote a brand or produce money, but for example even most charitable galleries, libraries, archives, and museums restrict people from sharing their free public content in this way. Consider contacting the WP:GLAM program for philosophical discussion of this. One reason for the practice is that historic institutions have always applied restrictive copyright to everything and changing any practice is difficult. As institutions give other reasons their reasons are documented in this WikiProject's public records.

7. Why does this project ask that researchers apply free copyright licenses to informed consent documents?

   Informed consent documents are public-facing documents and it has always been critical that communities approve of human subject research happening within them. There probably is no reasonable argument for saying that a community can understand the research happening within it without having easy access to the fundamental text document which describes the relationship which a research participant and a research coordinator have to a given clinical trial, and the informed consent document is that text document.

8. What can be done with an informed consent document which has a free license which cannot be done with one which has a non-free license?

   The most important thing is that people can legally share the document by republishing with annotations it in a community forum for public discussion along. Republishing and especially republishing with modifications are currently taboo in the clinical research industry, but in the lives of many research participants they actually would like to share copies of their documents with their social networks so that they can talk about the risks of participating in the same way that they would talk with others about healthcare decisions. Here are some examples of things which increase participant rights and which can only be legally done with freely licensed copies of the documents:

   1. Republishing the document in a public forum for anyone to see and give comment
   2. Annotating the document with hyperlinks leading to explanations of technical medical terms used in the document
   3. Distributing the document publicly with questions and notes in the margins
9. Why does this project not ask for the research protocol describing a clinical trial?

   An informed consent document is a relatively short and easy to understand document targeted to research participants to give them information about their personal participation in a clinical trial. A “research protocol” is a document which describes every aspect of conducting a clinical trial. It is often book-sized and a general researcher with a clinical protocol ought to be able to replicate the conduct of a clinical trial given only the protocol. It is an extensively detailed document.

   There are a few reasons why this project does not request access to research protocols. These reasons include the following:

   1. Research protocols are not publicly published and therefore not subject to direct review on Wikipedia per WP:VERIFIABILITY
   2. The integrity of a given clinical trial often depends on the privacy of the research protocol. For example, if a research participant becomes aware of the study measures in the research, that can predispose the participant to behaving differently during the study that participants who do not know the study measures. Part of the explanation for this phenomena can be explained by understanding the concept of research blinding.
   3. Research protocols have traditionally been under less public scrutiny than informed consent documents.
10. Why are the letters to clinical researchers sent publicly as open letters?

    The letters requesting information and informed consent documents from clinical researchers are sent openly for the following reasons:

    1. This process is a reasonable way to crowdsource the work to volunteers. Any volunteer can do the important work of making a research request and have community review for their actions if everything is done openly and transparently.
    2. The open letter format allows the process to be between the research organization managing the clinical trial and the community in a public forum rather than between individuals, so this relieves any individual person requesting information from doing every aspect of the information processing. To put all the work on a single person greatly increases the barrier for any individual to participate, and this project is a community effort.
    3. There is no particular benefit to doing this through closed, private letters.
11. What if a clinician refuses to share the clinical trial document or refuses to license it in a way that is compatible with upload to Wikimedia?

    There are several possible outcomes to a request for an informed consent document.

    1. The clinician licenses the document in such a way that the public can freely review it, annotate it, and share it amongst themselves. This increases public assent for clinical trials to happen in communities and greatly increases research participant rights by lowering the barrier to casual scrutiny over pharmacological research.
    2. The clinician refuses to respond to the request, and the open request remains permanently public on this website.
    3. The clinician requests more information on this project and posts to the talkpage.
    4. The clinician refuses to grant the request. Without extraordinary justification, many people would have trouble understanding how this response could do anything except maintain a barrier for the public to understand a clinical trial when there has been a public request to have the barrier to understanding lowered.
12. I have things to say about this project! Where can I discuss it?

    Please go to the talk page. Click “edit” at the top of that page. Scroll to the bottom of the text box and write what you like. Sign and timestamp your comment by writing four tildes (~~~~) after your comment.

13. Who is organizing this project?

    This, like all other projects on Wikipedia, are hosted by the website so long as the community agrees that the project advances the development of the encyclopedia. Anyone in the Wikipedia community may do as they like to organize the project. Any Wikipedia editors who want to name themselves as organizers of this project and receive occasional project notifications may do so by signing the participants list below.

Participants

1. Blue Rasberry (talk) 13:03, 8 December 2012 (UTC)