The revised Common Rule applying to research supported by DHHS 和 many other federal agencies (excluding FDA 和 DOJ), 于1月21日生效, 2019. This site provides an overview of the major changes 和 how the DU IRB implemented them.
主要规管变化
豁免
Categories have been updated, mostly to exp和 the type of research qualifying for exemption. 还增加了新的类别.
快速持续审查
Continuing review is no longer required for research approved through expedited review.
知情同意
Consent forms are now required to include a "Key Elements" section 和 new elements of informed consent are required in some circumstances. DU IRB consent form templates have been updated to reflect the regulatory changes.
单IRB记录
1月20日开始, 2020, federally-funded multi-site/collaborative research projects occurring in the U.S. will be required to use a single IRB review process.
小的监管变化
人类受试者研究
The definition of what qualifies as human subjects research has been updated to include identifiable biospecimens 和 to specifically exclude particular types of non-research activities.
放弃知情同意
In order to approve a waiver of informed consent, in addition to previously existing waiver criteria, the IRB must now also determine if the research involves using identifiable private information or identifiable biospecimens 和 whether the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
临床试验同意书
For each clinical trial supported by a federal department or agency, one IRB-approved informed consent form used to enroll subjects has to be posted by the PI on 临床试验.gov that will be established as a repository for such forms. The form must be posted on 临床试验.gov website after the clinical trial is closed to recruitment, 和 no later than 60 days after the last study visit by any subject.
Implementation of Regulatory Changes
- IRB form updates have been released 和 posted.
- Informed consent templates have been revised.
- IRB的政策 & 程序更新.
- The DU IRB did not implement Broad Consent or Exempt categories 7 & 8.
New Studies approved January 21, 2019 和 later:
- Studies approved after January 21, 2019 were approved in compliance with the New Common Rule.
- Expedited 和 Exempt review projects were issued a Next Report Due date. 教师 和 staff investigators were issued a two-year review period 和 student investigators were issued a one-year review period.
- The DU IRB will serve as a single IRB in limited circumstances. Consult with IRB staff prior to submitting an application in these cases.
Studies approved before January 21, 2019:
- Existing exempt studies will remain unchanged unless an amendment submission requires a re-categorization.
- Studies approved via Expedited or Full Board review were evaluated at the time of continuing review to determine if they were eligible for reclassification.
- Federally funded studies approved via Expedited review were issued expiration dates; non-federally funded studies approved via Expedited review were issued a Next Report Due date. 教师 和 staff investigators were issued two-year review periods 和 student investigators were issued a one-year review period.
- Studies granted an Exempt status were issued a Next Report Due date. 教师 和 staff investigators were issued a two-year review period 和 student investigators were issued a one-year review period.
- At the end of the designated review period, PI are requested to provide the IRB with a status report of their project. Notices are sent prior to the assigned Next Report Due date 和 investigators are requested to submit a Project Status Report for ongoing projects or a Final Report for studies that have been completed.
