What needs to be reviewed?
All research utilizing recombinant DNA or synthetic nucleic acid molecules must adhere strictly to the NIH Guidelines. Ensuring compliance with these guidelines is the responsibility of the principal investigator (Sec. IV-B-7-a, NIH Guidelines). Biohazardous materials (i.e. human tissue & fluid) also require IBC registration as per Indiana University policy, even though they are not regulated by the NIH Guidelines. As a principal investigator, you can ask one question when determining what research requires Institutional Biosafety Committee (IBC) review:
"Does this research fall under Sec. III of the NIH Guidelines?"
A protocol submission is required when research includes one or more of the following:
- Work involving viral vectors, plasmid vectors, or other infectious agents,
- Transgenic/Knock-out animals (see OBA Transgenic Animal FAQs),
- Transfer of recombinant DNA or synthetic nucleic acid molecules into human participants,
- Genetically modified plants,
- Transactive or infectious proteins,
- Prion protein,
- Biohazards (i.e. human tissue & fluid), and
- Exempt research (Sec. III-F, NIH Guidelines)
*Note: that exempt experiments only require IBC administrator and
Biosafety Office review, NOT full IBC review