Click the links below to find more information:
You will need to register if your research involves the use of any of the following:
Section 1-B Definition of Recombinant DNA Molecules.
In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.
Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH Guidelines. Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to the NIH Guidelines unless the transposon itself contains recombinant DNA
Yes; all research projects have to be registered because our institution gets research support from the NIH. The requirement for registration applies even to projects that are not supported by the NIH.
(see http://osp.od.nih.gov/office-biotechnology-activities/oba/index.html, section 1-D, Compliance with the NIH Guidelines)
All personnel that are involved in the project.
The documents are available on the Forms page. There are checklists for different registration categories.
Documents are submitted through the Office of Research by persons applying for extramural funding. For other researchers, documents should be submitted to the committee chair.
No, that form is to be used by any researcher who works with tissues or cells from humans or from any other primate (typically monkey). The CDC recommends that all primate cells be used at BSL-2 containment. That includes established human or monkey cell line as will as tissue or blood samples. Here is an example .
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