The Catholic University of America

Summary of Federal Laws

Research

CUA Compliance Partners

Industrial Hygienist/Biosafety Officer

Federal Policy on Recombinant DNA

NIH Guidelines for Research Involving DNA Molecules

Any institution that sponsors recombinant DNA research that is covered by the National Institutes of Health (NIH) guidelines must make sure that the appropriate level of review occurs by the Institutional Biosafety Committee, and that any required petitions are submitted to the NIH. The NIH guidelines are available online. The most recent Federal Register notices may also be accessed at this site.

The IBC must have at least five members. Details on committee membership can be found in Section IV-B-2 of the NIH Guidelines. Two members must be persons not affiliated with the institution who represent the interest of the surrounding community with respect to protection of the health and safety of the environment. Registration of the IBC with NIH (Office of Biotechnology Activities) is required.

The institution must file an annual report that includes the following:

1) An updated committee roster indicating the role of each committee member and

2) Biosketches for each member of the committee. This this can be a CV or resume.

The cover letter should indicate that this info is being submitted as the IBC's annual report.

There is an ongoing obligation to notify OBA of any changes in committee membership when they occur. If changes do occur, the report should include a revised roster, with new members and their contact information and a resume.

The Biosafety Committee must report any significant problems or violations of the NIH Guidelines or an significant research related accidents and illnesses to NIH OBA within 30 days. Incident reporting is also a responsiblity of insitutions, Biosafety Offices, and principal investigators. Institutions may coordinate which party will make the report on behalf of the institution.

Resources

Office of Biotechnology Activities  (Guidance on IBCs)
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CUA Form for Registration of Recombinant DNA Experiments


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updated 3-3-17