1. Research as defined by DHHS A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]

2. Human subject as defined by DHHS a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

3. Clinical investigation as defined by FDA any experiment that involves –a test article, and –one or more human subjects, and – that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

4. Human subject as defined by FDA An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g) and 21 CFR 56.102(g)]

5. Test article as defined by FDA any drug, medical device for human use, human food additive, color additive, electronic product or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).

6. IND/IDE Applications Sponsor – a person who takes responsibility for and initiates a clinical investigation (21 CFR Parts 312.3 and 812.3) Sponsor Investigator (SI) – a person who both initiates and conducts an investigation, and under whose immediate direction the investigational product is administered or dispensed (21 CFR Parts 312.3 and 812.3) UC SIs are required to submit IND/IDE applications to IAP (broag@uc.edu) prior to submission to FDA (Policy III.08)broag@uc.edu Sponsor required to establish ownership of data and terms of use in legal agreements

7. ClinicalTrials.gov Mandated by FDA Amendments Act (Public Law 110-85, Title VIII, Section 801) UC maintains institutional account; investigators need to contact UCORI at researchcompliance@uc.edu to accessresearchcompliance@uc.edu Penalties for responsible parties (check contracts!) who do not register applicable trials may include notices of noncompliance, monetary sanctions (up to $10K per day), withholding or recovery of grant funds for federally funded trials as well as publishing restrictions

8. ePAS Rights are currently being built into ePAS for SRS and other administrative reviewers. As we continue to merge the Gateway and ePAS there will continue to be 2 places to look. You will login to ePAS here: https://epas.research.cchmc.org/ePAS_PRD using your central login https://epas.research.cchmc.org/ePAS_PRD

9. Vertebrate Animal Research Animal – Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. -Public Health Service Policy on Humane Care and Use of Laboratory Animals, August 2002 Use in teaching and in field studies requires IACUC Approval

10. Is IACUC approval Required? IF the VAS section of the grant is filled out, IACUC Approval is likely required. Grants compliance form lists animal work. Any Vertebrate animal purchase not from a grant.

11. Animal work not performed at UC Now covered using Grants Compliance form Verification of external approval by IACUC is no longer required

12. IBC oversight (1) Recombinant DNA (rDNA) As defined by the NIH Guidelines, recombinant DNA molecules are either: (1) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (2) DNA molecules that result from the replication of those described in (1). There is no box to check or keyword on NIH forms, the PI should check box on ePRF.

13. IBC oversight (2) Select Agent Research (right after Vertebrate Animals/before multiple PD/PI plan for NIH) Infectious Agents (e.g. viruses, bacteria, fungi, protozoa, prions, transducible proteins-TAT) Human derived materials (human blood, tissues, cells) Human gene transfer (transferring rDNA into humans)

14. Institutional Review Board (IRB) http://researchcompliance.uc.edu/HSR/IRB/Overview.aspx Email: irb@uc.eduirb@uc.edu 513-558-5259 IND/IDE Assistance Program (IAP) http://researchcompliance.uc.edu/FDA Email: angela.braggs-brown@uc.eduangela.braggs-brown@uc.edu 513-558-3005 Institutional Animal Care and Use Committee (IACUC) http://researchcompliance.uc.edu/iacuc Email: iacuc@ucmail.uc.eduiacuc@ucmail.uc.edu 513-558-5187 Biosafety Office /Institutional Biosafety Committee (IBC) http://researchcompliance.uc.edu/biosafety Email: inbiocom@ucmail.uc.eduinbiocom@ucmail.uc.edu 513-558-6182

15. RCR training for NSF For trainees : CITI training NOTE: there are many courses available through CITI you are only required to take 1 of the RCR courses to complete this requirement. BE AWARE THAT Biomed, SBR, Physical Sciences, Arts/Humanities have the same 11 modules (and satisfy the NSF requirement); however, Engineering has 17 modules and is most divergent with NSF guidance. Therefore, while we will accept completion of the Engineering RCR course, we discourage it and encourage completion of 1 of the other courses.

16. RCR training for NSF For PIs : TO CERTIFY, REPLACE THE RED TEXT, BELOW, WITH THE NAMES OF YOUR TRAINEES, ABOVE, DELETE THE TEXT ABOVE AND REPLY TO ME. THANK YOU As the Principal Investigator of an NSF award I hereby certify that (trainee names) will be mentored in responsible conduct of research. In particular, I will insure that (s)he will receive ongoing training in RCR (who is responsible for what, including PI’s responsibility), Laboratory/research safety (obligation to others around us) Conflicts of interest/commitment, Authorship and Publication (attribution of credit/sharing of reagents and data), Collaborative Research, Data Acquisition and Management, Intellectual property, Mentoring, Research Misconduct, Peer Review If this project includes recombinant DNA, infectious agents, human subjects, or vertebrate animals I certify that (trainee names) will complete the required additional training and will be added an approved protocol.