Guidelines

The NIH Guidelines are applicable to:

All recombinant or synthetic nucleic acid research within the United States (U.S.) or its territories that is within the category of research described in either Section I-C-1-a-(1) or Section I-C-1-a-(2).

Section I-C-1-a-(1). Research that is conducted at or sponsored by an institution that receives any support for recombinant or synthetic nucleic acid research from NIH, including research performed directly by NIH. An individual who receives support for research involving recombinant or synthetic nucleic acids must be associated with or sponsored by an institution that assumes the responsibilities assigned in the NIH Guidelines.

Section I-C-1-a-(2). Research that involves testing in humans of materials containing recombinant or synthetic nucleic acids developed with NIH funds, if the institution that developed those materials sponsors or participates in those projects. Participation includes research collaboration or contractual agreements, not mere provision of research materials.

Section I-C-1-b. All recombinant or synthetic nucleic acid research performed abroad that is within the category of research described in either Section I-C-1-b-(1) or Section I-C-1-b-(2).

  • Section I-C-1-b-(1). Research supported by NIH funds.
  • Section I-C-1-b-(2). Research that involves testing in humans of materials containing recombinant or synthetic nucleic acids developed with NIH funds, if the institution that developed those materials sponsors or participates in those projects. Participation includes research collaboration or contractual agreements, not mere provision of research materials.
  • Section I-C-1-b-(3). If the host country has established rules for the conduct of recombinant or synthetic nucleic acid molecule research, then the research must be in compliance with those rules. If the host country does not have such rules, the proposed research must be reviewed and approved by an NIH-approved Institutional Biosafety Committee or equivalent review body and accepted in writing by an appropriate national governmental authority of the host country. The safety practices that are employed abroad must be reasonably consistent with the NIH Guidelines.

Section I-D. Compliance with the NIH Guidelines As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines. Information concerning noncompliance with the NIH Guidelines may be brought forward by any person. It should be delivered to both NIH OSP and the relevant institution. The institution, generally through the Institutional Biosafety Committee, shall take appropriate action. The institution shall forward a complete report of the incident recommending any further action to the Office of Science Policy, National Institutes of Health, preferably by e-mail to: NIHGuidelines@od.nih.gov; additional contact information is also available here and on the OSP website (www.osp.od.nih.gov). In cases where NIH proposes to suspend, limit, or terminate financial assistance because of noncompliance with the NIH Guidelines, applicable DHHS and Public Health Service procedures shall govern. The policies on compliance are as follows:

  • Section I-D-1. All NIH-funded projects involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines. Non-compliance may result in: (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant or synthetic nucleic acid molecule research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecule projects at the institution.
  • Section I-D-2. All non-NIH funded projects involving recombinant or synthetic nucleic acid molecule conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines. Noncompliance may result in: (i) suspension, limitation, or termination of NIH funds for recombinant or synthetic nucleic acid molecule research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecule projects at the institution.

Source: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 2016)