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Research Regulatory Review Form

Research Regulatory Review

To be completed by PI’s and other researchers at least annually to confirm all appropriate reviews have been done.

This field is for validation purposes and should be left unchanged.

Please answer all questions as required, and submit upon completion. This form should be completed at least once a year for each Principal Investigator or Researcher.
Name(Required)

Biohazards and Recombinant DNA

Individuals or laboratories planning on using recombinant DNA in research must first file an application with the Wake Forest University Institutional Biosafety Committee (IBC).
Will research involve Recombinant DNA?(Required)
Investigators are reminded that they must adhere to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) when they perform research that is conducted at or sponsored by an entity receiving any NIH support for recombinant DNA research. Therefore, even privately funded projects employing recombinant DNA must adhere to the NIH Guidelines if they are being carried out at, or funded by, an organization that has any NIH contracts, grants, or other support for this kind of research.
Will research involve the use of human blood, bodily fluids, tissue, or organs?(Required)
Will Select Agents be used in the research as listed by the Centers for Disease Control and United States Department of Agriculture?(Required)
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188 requires the Department of Health and Human Services (HHS) to establish and regulate a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002 requires the United States Department of Agriculture (USDA) to establish and regulate a list of biological agents that have the potential to pose a severe threat to animal health and safety, plant health and safety, or to the safety of animal or plant products (Select Agents). CDC and APHIS share responsibility for some agents because they potentially threaten both humans and animals (overlap agents).

Human Participants

The Reynolda Campus Institutional Review Board (IRB) protects the rights and welfare of human participants involved in research conducted under the auspices of Wake Forest University, in accordance with its Federal-wide Assurance and 45 CFR §46. If you are unsure if your research requires IRB approval please contact the Office of Research and Sponsored Programs.

Use of Animals in Research

Any work involving the use of animals in research must be reviewed and approved by the Animal Care and Use Committee.
Are animals to be used during the research?(Required)

Research Activities Involving Radioactivity

The Radiation Safety Office the research and clinical uses of radioactive materials and radiation producing equipment throughout the WFU. Working with the General Radiation Safety Committee (research use) and the Medical Radiation Safety Committee (clinical use) this program offers extensive services in order to ensure compliance with state and federal radiation safety and security regulations.
Are Radioisotopes to be used in the research?(Required)
Will non-ionizing radiation sources be used in the research?(Required)
Lasers, Ultraviolet radiation (UV), infrared radiation (IR), Microwave radiation (MW), or Extremely Low Frequency (ELF) radiation.
Will X-Ray radiation be used in research?

Chemical Hazards

Will pyrophoric or explosive chemicals be used in the research?
Will any Particularly Hazardous Substances as cited under 29 CFR 1910.1450 (e)(3)(viii) be used in the research?
These substances include Carcinogens, Reproductive Toxins, and Acutely Toxic Substances.
Will Controlled Substances be used in the research?
The PI must register with the DEA and obtain a DEA license prior to accepting possession of a controlled substance

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