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Publication of IRB Opinions


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<h2>Publication of IRB Opinions</h2> <p>By transparently displaying its minutes publicly, the Institutional Review Board (IRB) creates case law which may be cited by courts and/or other IRBs as persuasive precedent or <em>jurisprudence constante</em> when dealing with the thorny issues of science not yet covered by statutes and regulations. Out of respect for other IRBs and courts, and to prevent investigators from shopping-around for favorable IRB results, the process for publishing opinions is formalized as follows:</p> <ol> <li>The author constructs a document which begins with the number assigned to the IRB by the Office for Human Research Protections (displayed on IRB's front page), the title of the opinion (e.g. "IRB Opinion about Replication of Fisher (2007)"), the author's name, and the date(s) of authoring. </li> <li>This is followed by a "<strong>Decision</strong>" section which includes the date of the vote, the decision made, the attendees of the meeting in which the vote was called, the number of votes for and against, specification of which attendees did not vote, and explanation of why each did not vote (e.g. declared conflicts of interest).</li> <li>This is followed by a "<strong>Facts</strong>" section which includes the URL of the Open Science Framework (OSF) project where the opinion will be posted, and lists relevant facts of the case (if any) beyond what is already specified in that project. Fact are relevant if future researchers might use them to determine similarity to future cases. </li> <li>This is followed by a "<strong>Precedents</strong>" section which lists previously published opinions (if any) considered in the meeting and, for each, whether it was affirmed by this opinion.</li> <li>This is followed by a "<strong>Considerations</strong>" section which lists all ethical considerations acknowledged in the meeting. That includes all ethical considerations described in listed precedents, all considerations identified by the investigators, and any additional considerations identified in the meeting.</li> <li>This is followed by a "<strong>Reasoning</strong>" section which explains how each ethical consideration was addressed and, if this opinion differed from any considered precedents, why. The reasoning may cite new evidence, new regulations or statutes, new methods to address considerations, and/or changes in social opinion. Reasoning may largely be copied from the application by investigators, but additional considerations may have been raised and addressed in the meeting. </li> <li>The author posts the opinion document to the OSF project with a link to it at the top of the project wiki (see <a href="" rel="nofollow">How to use OSF</a>), and adds tags to the project for "IRB Opinion" and any keywords for the research (e.g. names of procedures, materials, effects, populations, concepts, etc.)</li> <li>The author notifies the other board members (e.g. via group email), giving them two weeks to append dissenting or concurring opinions. This invitation is expected to occur with a week after the vote took place.</li> <li>Board members who voted review the draft opinion, and add sections to the end if they believe anything was left out. Sections authored by board members who voted against the majority are titled "<strong>Dissenting Opinion</strong>" and sections by others are titled "<strong>Concurring Opinion</strong>". Such opinions are followed by their authors' names, the date(s) of authoring, and any relevant information their authors believe the original author left out.</li> <li>When the two weeks are up, the original author reviews the document to confirm that it was not corrupted, confirms that only board members are listed as contributors to the project, registers the OSF project publicly, and requests a DOI and ARK. This freezes a version of the opinion and facilitates citation in scholarship and future opinions.</li> <li>The original author should consider whether the process of forming the opinion exposed opportunities to refine Wikipedia (especially in the categories of <a href="" rel="nofollow">Research ethics</a> or <a href="" rel="nofollow">Clinical research ethics</a>). Other IRBs are more likely to seek information in Wikipedia than in the published opinion, so the original author should endeavor to contribute any appropriate adjustments to Wikipedia as well. </li> </ol>
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