Biohazardous materials include human biological specimens, infectious agents, recombinant material, and gene therapy. Biological toxins and carcinogens are also included if they are used in conjunction with animals. The following trainings are required before investigators can be given approval to ship biohazardous materials or use them in teaching or research. The following CITI trainings are required dependent on the nature and use of the materials and must be taken yearly:

The Office of Sponsored Programs (OSP) oversees the proposal submission process and negotiates contractual terms and conditions of awards, with the goal of promoting, fostering and sustaining excellence in basic and clinical research.

The National Institutes of Health (NIH) requires researchers to acknowledge federal funding in peer-reviewed publications by citing any NIH grants that supported the research process described in the publication. In addition, the NIH Public Access Policy requires that all investigators “funded by the NIH,” be it through direct funding or through use of resources of an NIH-funded center (such as Penn State Clinical and Translational Science Institute) submit an electronic version of their final, peer-reviewed manuscripts to PubMed Central (PMC) upon acceptance of publication.

For drugs, according to 21 CFR 312.62(c), an investigator shall retain records required to be maintained under the part for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the applications is not approved for such indication, until two years after the investigation is discontinued and FDA is notified.