Developing a proposal that includes work with animals, human participants, recombinant or synthetic nucleic acid molecules (r/sNA), or hazardous materials (biological, chemical, or radiation) requires careful planning. It may require institutional approval; may be regulated at the federal or state level; or may require specialized infrastructure or controls.
Work Requiring Institutional Committee or Office Approval
For research with animals, human participants, r/sNA, certain biological materials, and radiation, institutional approval will be required before funding can be released; in some cases, approval will be required even sooner (e.g., "Just in Time" requests). In general, we recommend you start work on your compliance protocols at the proposal stage:
- IACUC protocol (live vertebrate animals)
- IRB protocol (humans)
- IBC MUA (r/sNA or biohazards)
- Radiation Safety approval
If you are seeking NIH funding for a multi-site human participant research study, your project may require a Single IRB ("sIRB") Plan. Contact the IRB office well in advance of submitting your proposal to discuss.
Specific Requirements for Hazardous Materials and Equipment
The purchase and use of certain types of materials and equipment may be regulated at the federal or state level or may necessitate specialized monitoring equipment, infrastructure, or controls. It is important to identify these requirements and the associated time and financial costs early in the planning process so they can be properly budgeted for and prevent a delay in starting your project.
- Recombinant or synthetic nucleic acid molecules
- Biological agents classified as Risk Group 2, 3, and 4
- Select agents and toxins
- Radioactive materials and radiation producing equipment
- Class 3B and 4 lasers
- Controlled substances
- Toxic and flammable gases
- Chemicals with special storage or handling requirements (i.e. pyrophoric)
- Equipment with special ventilation requirements
The contacts and webpages listed here can provide you with guidance on the compliance and safety-related aspects of your proposed research:
- IACUC office; homepage for animal work
- IRB office; homepage for human research
- IBC office; homepage for work with r/sNA or biohazards
- EHS Research Safety office; homepage for research safety
- Some funding agencies, such as the DOE, require the completion of an environmental compliance questionnaire as part of the grant application process. Environment, Health and Safety (EHS) will assist with the completion of these questionnaires. Because some questionnaires are lengthy and complex, please allow five (5) days for completion. Submit the request for assistance via askEHS and include “Environmental Certification” in the subject line.
- You don't have to complete your research protocol before submission of a funding proposal, but you should understand the process and requirements.
- Contact the appropriate compliance group (above) during or after proposal submission. For some sponsors, the window to complete the protocol is short (e.g., the IACUC protocol deadline is short for NIH and USDA). If the campus group knows protocols are coming, it helps to keep things on schedule.
- In some cases, you and your staff may be required to complete training before you can begin work. Learn more about relevant training requirements in the Compliance, Ethics, Safety section of this website.
- Be aware that personnel who work with select agents and irradiators require federal background checks.
- Training is required for personnel who will work with animals, human participants, human biomaterials, or bloodborne pathogens. Learn more:
Detailed information about working with animals, human participants, r/sNA, hazardous material, or radiation is in the Compliance, Ethics, and Safety section.