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<NewsItem contentIssues="false" id="10893" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/10893">
<Title>Report on Human Subjects Protections</Title>
<Body>
<![CDATA[
    <div class="html-content"><div>The Presidential Commission for the Study of Bioethical Issues has recommended changes to current practices to better protect research subjects and to improve its tracking of research programs supported with taxpayer dollars.</div><div><br></div><div>See more at <a href="http://bioethics.gov/cms/node/559" rel="nofollow external" class="bo">bioethics.gov/cms/node/559</a></div><div><br></div><div>The report that discusses these recommendations may be viewed at <a href="http://bioethics.gov/cms/sites/default/files/PCSBI-IRP_Research-Across-Borders.pdf" rel="nofollow external" class="bo">bioethics.gov/cms/sites/default/files/PCSBI-IRP_Research-Across-Borders.pdf</a></div></div>
]]>
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<Summary>The Presidential Commission for the Study of Bioethical Issues has recommended changes to current practices to better protect research subjects and to improve its tracking of research programs...</Summary>
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<PostedAt>Thu, 15 Dec 2011 09:23:40 -0500</PostedAt>
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<NewsItem contentIssues="true" id="10785" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/10785">
<Title>Updated IRB forms and applications</Title>
<Body>
<![CDATA[
    <div class="html-content"><div>Please use the most up to date forms and applications when submitting for IRB review and approval. Using older forms may delay the processing of your application (and causing minor headaches for the Office for Research Protections and Compliance staff!).</div><div><br></div><div>The direct link to these forms is: <a href="http://www.umbc.edu/research/ORPC/irb_forms.html" rel="nofollow external" class="bo">http://www.umbc.edu/research/ORPC/IRB_formsandtemplates.html</a></div></div>
]]>
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<Summary>Please use the most up to date forms and applications when submitting for IRB review and approval. Using older forms may delay the processing of your application (and causing minor headaches for...</Summary>
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<PostedAt>Fri, 09 Dec 2011 10:16:13 -0500</PostedAt>
<EditAt>Fri, 16 Nov 2012 10:12:58 -0500</EditAt>
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<NewsItem contentIssues="false" id="10689" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/10689">
<Title>2012 Edition of OHRP International Compilation</Title>
<Body>
<![CDATA[
    <div class="html-content"><div>OHRP has released the 2012 edition of the International Compilation of Human Research Standards which lists over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Two new countries are included in the 2012 Edition: Barbados and Haiti.</div><div><br></div><div>Go to <a href="http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html" rel="nofollow external" class="bo">this link</a> for more information.</div></div>
]]>
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<Summary>OHRP has released the 2012 edition of the International Compilation of Human Research Standards which lists over 1,000 laws, regulations, and guidelines on human subjects protections in over 100...</Summary>
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<PostedAt>Mon, 05 Dec 2011 12:15:41 -0500</PostedAt>
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<NewsItem contentIssues="true" id="10611" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/10611">
<Title>OLAW Position Statements regarding updated Guide</Title>
<Body>
<![CDATA[
    <div class="html-content"><div>The Office for Laboratory Animal Welfare (OLAW) has released information about their adoption of the new edition of the Guide for Use of Laboratory Animals (<span><a href="http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf" rel="nofollow external" class="bo">8th Edition</a></span>). OLAW requests public comment on various position statements they plan to use as guidance for institutions to use for animal care and use programs.</div><div><br></div><div>Please go to this site (<a href="http://grants.nih.gov/grants/olaw/2011positionstatement.htm" rel="nofollow external" class="bo">http://grants.nih.gov/grants/olaw/2011positionstatement.htm</a>) to view these statements and for links to submit comments. The public comment period ends on <span>January 30, 2012.</span></div></div>
]]>
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<Summary>The Office for Laboratory Animal Welfare (OLAW) has released information about their adoption of the new edition of the Guide for Use of Laboratory Animals (8th Edition). OLAW requests public...</Summary>
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<PostedAt>Fri, 02 Dec 2011 09:13:45 -0500</PostedAt>
<EditAt>Fri, 02 Dec 2011 09:14:22 -0500</EditAt>
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<NewsItem contentIssues="false" id="10335" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/10335">
<Title>Rethinking the "Common Rule"</Title>
<Tagline>Interested in learning about human research regulations?</Tagline>
<Body>
<![CDATA[
    <div class="html-content"><div><div><h6>November 21, 2011 at 1:00 pm.</h6><h6><br>Tune in to WAMU's Kojo Nnamdi Show for a discussion "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects". The show features Jerry Menikoff, Director, Office for Human Research Protections (OHRP) and Kathy Hudson Deputy Director for Science, Outreach, and Policy, National Institute of Health.</h6></div></div></div>
]]>
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<Summary>November 21, 2011 at 1:00 pm.   Tune in to WAMU's Kojo Nnamdi Show for a discussion "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects". The show features Jerry Menikoff,...</Summary>
<Website>http://thekojonnamdishow.org/shows/2011-11-21/rethinking-common-rule-ethics-research-human-subjects</Website>
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<PostedAt>Thu, 17 Nov 2011 22:58:06 -0500</PostedAt>
<EditAt>Thu, 17 Nov 2011 22:59:35 -0500</EditAt>
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<NewsItem contentIssues="false" id="8609" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/8609">
<Title>UMBC's FWA has been renewed</Title>
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<![CDATA[
    <div class="html-content"><span>University of Maryland, Baltimore County's Federalwide Assurance (FWA00000069) is approved through 09/13/2016). </span></div>
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<Summary>University of Maryland, Baltimore County's Federalwide Assurance (FWA00000069) is approved through 09/13/2016). </Summary>
<Website>http://harponotes.blogspot.com/</Website>
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<PostedAt>Tue, 13 Sep 2011 11:21:00 -0400</PostedAt>
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<NewsItem contentIssues="false" id="8309" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/8309">
<Title>Comment period on proposal to improve rules changes</Title>
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<![CDATA[
    <div class="html-content"><div><div><span>The comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects has changed and will end, on October 26, 2011. See the September 1, 2011 Federal Register (<a href="http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/pdf/2011-22341.pdf" rel="nofollow external" class="bo">http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/pdf/2011-22341.pdf</a>)</span></div><div><br></div></div></div>
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<Summary>The comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects has changed and will end, on October 26, 2011. See the September...</Summary>
<Website>http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/pdf/2011-22341.pdf</Website>
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<PostedAt>Thu, 01 Sep 2011 12:54:29 -0400</PostedAt>
<EditAt>Mon, 12 Sep 2011 13:24:27 -0400</EditAt>
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<NewsItem contentIssues="false" id="8047" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/8047">
<Title>Conflict of Interest Rules Finalized for NIH</Title>
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<![CDATA[
    <div class="html-content"><span>The Department of Health and Human Services has issued an updated final rule on conflict of interest to use in identifying, managing, and avoiding investigators’ financial conflicts of interest. The r</span>egulations will be implemented after publication of the final rule in the Federal Register.<div><br></div><div><span><p>Major changes to the regulations include:</p><ul><li>A requirement for investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.</li><li>Lowering the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.</li><li>Requiring institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.</li><li>Requiring institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.</li><li>Requiring investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.</li></ul></span></div><div>See this site, <a href="http://www.nih.gov/news/health/aug2011/od-23.htm" rel="nofollow external" class="bo">http://www.nih.gov/news/health/aug2011/od-23.htm</a>, for more information and a full description of the major changes to the regulations.</div></div>
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<Summary>The Department of Health and Human Services has issued an updated final rule on conflict of interest to use in identifying, managing, and avoiding investigators’ financial conflicts of interest....</Summary>
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<PostedAt>Wed, 24 Aug 2011 13:20:20 -0400</PostedAt>
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<NewsItem contentIssues="false" id="8006" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/8006">
<Title>Changes to human subjects protection regulations</Title>
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<![CDATA[
    <div class="html-content"><div>The Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, proposing substantial changes to the federal regulations governing human subjects protections known as the 'Common Rule.’</div><div><br></div><div>The public comment period is scheduled to be open through September 26, 2011.</div><div><br></div><div>The attached a table from OHRP that compares the changes of the current regulations and the proposed wording. </div><div><br></div></div>
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<Summary>The Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections:...</Summary>
<Website>http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html</Website>
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<NewsItem contentIssues="false" id="7071" important="false" status="posted" url="https://beta.my.umbc.edu/groups/carat/posts/7071">
<Title>Updates to examples of exempt review chart</Title>
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<![CDATA[
    <div class="html-content">ORPC has updated the <span><a href="http://www.umbc.edu/research/ORPC/IRB_exemptrprocess.html" rel="nofollow external" class="bo">Exempt Category Example Chart</a></span><span> to assist investigators in determining if their research fits into one or more of the exempt categories. </span></div>
]]>
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<Summary>ORPC has updated the Exempt Category Example Chart to assist investigators in determining if their research fits into one or more of the exempt categories. </Summary>
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