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What NIH-funded research is issued a Certificate?
Effective October 1,certificates are automatically issued by NIH for all research covered by the policy that was commenced or ongoing on or after December 13, To determine if this Policy applies to research conducted or supported by NIH, investigators will need to ask, and answer the following question: Is the activity biomedical, behavioral, clinical, or other research?
If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions: Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
Does the research involve the generation of individual level, human genomic data? If the answer to any one of these questions is yes, then this Policy will apply 3. It is the responsibility of recipients and their investigators to determine if their research is collecting or using covered information.
No, NIH will not provide documentation that specific NIH-funded studies are covered by a Certificate after the effective date of the policy. Does the Policy issue certificates to NIH-funded 13 characteristics of the digital student that began after the enactment of section of the 21st Century Cures Act on December 13, ?
Section of the 21st Century Cures Act covers all research begun on or after December 13,and all research ongoing as of that date.
Therefore, all NIH research within the scope of the policy, that was ongoing on December 13,or initiated on or after that date, is issued a certificate.
Note that research that was previously issued a Certificate by NIH regardless of the funding source is also subject to the new protections and requirements put in place by the 21st Century Cures Act. Does the policy issue Certificates to studies covered by a Certificate issued prior to October 1, ?
For certificates issued prior to December 13,for research that no longer has NIH funding, a new certificate will not be issued. However, the new protections and requirements enacted by the 21st Century Cures Act apply to all certificates previously issued by NIH, regardless of the funding source.
Does the protection afforded by a Certificate change if the Certificate was issued prior to the date of enactment of section of the 21st Century Cures Act Pub. NIH has long interpreted the protection afforded by Certificates to be permanent, even after a Certificate expires.
Information protected by a Certificate that was issued or expired prior to the enactment of section of the 21st Century Cures Act will be subject to the requirements of the statute, which protects all copies of the information in perpetuity.
Does a Certificate protect all identifiable, sensitive information collected or used during the duration of a research project?
For NIH funded research, a Certificate protects the information that was collected or used during the period in which the research is funded by NIH.
If the study continues after your NIH funding ends and you need continued protection of a Certificate for new information, you should apply for a Certificate following the process for non-federally funded research. You may want continued protection, for example, if you were collecting new information from participants or enrolling new participants after the period in which the research was funded by NIH.
Note that information protected by a Certificate, and all copies thereof, is protected by a Certificate in perpetuity, even after the research is no longer funded by NIH. If a research project was issued a Certificate and continues under a no-cost extension, the research is considered to continue to be covered by the Certificate for the duration of the no-cost extension.
Are investigators who conduct secondary research with information protected by a Certificate required to apply for a Certificate? Certificates may be issued for non-federally funded research upon request, but are not mandatory. Information protected by a Certificate and all copies are subject to the protections of the Certificate in perpetuity.
Therefore, if a secondary researcher receives information protected by a Certificate the secondary researcher is required to uphold the protections of the Certificates. NIH expects that recipients of a Certificate will inform secondary researchers when information disclosed to them is protected by a Certificate.
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Discovery Education ignites student curiosity and inspires educators to reimagine learning with award-winning digital content and professional development. Accelerate student achievement by capturing the minds and imaginations of students. Visit us online and learn more! English Language Arts Standards» Introduction» Students Who are College and Career Ready in Reading, Writing, Speaking, Listening, & Language.
Here I want to discuss one key component of a learning environment, learner characteristics, and in particular focus on the characteristics of learners that are particularly relevant for designing teaching and learning in a digital age.
A Case Study profiling a student with an Autism Spectrum Disorder or their family is found at the beginning of every chapter.
These real-life stories will provide authentic examples to which to tie key concepts and content. (See a Case Study example, Matt and Shannon, Chapter 4). Generation Z or Gen Z, also known by a number of other names is the demographic cohort after the Millennials (Generation Y).
There is no precise date for when Generation Z begins, but demographers and researchers typically use the mids to mids as a starting birth years.