IRB Advisor – September 1, 2018
September 1, 2018
View Issues
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Does Use of Biospecimens From Children Require Reconsent When They Are Adults?
There is considerable ethical debate about the issue of reconsent at age 18 from research subjects who provided biospecimens as infants, children, or adolescents. Practices currently vary widely among institutions.
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Tackling AAHRPP Accreditation Requires Time, Focus, Documentation
Research institutions seeking first-time accreditation or reaccreditation can always expect challenges. These hurdles are a little higher now as rules and regulations will change in 2019 under the new Common Rule.
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Newly Accredited Program Has Made Policies and Procedures Easier to Follow
When the human research protection program at the University of Florida decided to undergo accreditation with the Association for the Accreditation of Human Research Protection Programs, officials revised policies and procedures, making them consistent across IRBs and easy to follow.
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Consistency Is a Challenge, but Necessary With Multiple Institutional IRBs
Research institutions that undergo accreditation preparation quickly learn that having separate policies and procedures for each IRB is a problem.
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FDA Gene Therapy Draft Calls for Long-term Follow of Subjects
The FDA recently issued multiple draft guideline documents on the fast-emerging field of gene therapy, including guidance on specific diseases like hemophilia and the need to follow some research subjects long-term to assess delayed adverse events.
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Potential Adverse Outcomes of Gene Therapy
Gene therapy may warrant long-term follow-up of research subjects due to the risk of delayed adverse events.
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SACHRP on Verge of Finalizing Informed Consent Guidance
The Secretary’s Advisory Committee on Human Research Protections expects later this year to finalize guidance related to the new Common Rule.