Application for Human Subjects Research Certification for All Investigators and Key
RENEWAL Application for Human Subjects Research Certification
Page 1 of 2Human Subjects Research Certification -- Renewal Application
Version 7/17
Section I:Personal/Contact Information [PLEASE TYPE]
Name:Phone: / E-mail:
Please review this application carefully and complete all required information. You will need to submit asignedcopy of this document via email to the RSPP Office (). Please keep the original application for your records. Your application may be returned to you if your application is incomplete.
Page 1 of 2Human Subjects Research Certification -- Renewal Application
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Section II: Research Certification Agreements & Requirements
ANY KEY PERSONNEL WHO IS INVOLVED IN THE CONDUCT OF HUMAN SUBJECT RESEARCH AT ANY AURORA FACILITYMUST…Element
1 / On-line training (CITI course) / … Complete the RENEWALon-line training course in CITI. Note: you will need the user name and password you originally used in CITI to access the Renewal course. If you cannot recall your user name and/or password, the CITI website includes instructions on how to obtain assistance.By checking this box, you are attesting that you have personally completed the CITI Renewal training course. The RSPP Office will access CITI to obtain a copy of your completion certificate – you do not need to append it to this application.
2 / Agree to abide by the overseeing IRBs (Aurora IRB or external IRB) Standard Operating Procedures (SOP) / …Agree to abide by the overseeing IRBs (Aurora IRB or external IRB) SOPs in the conduct of human subject research at Aurora Health Care. You can access/review the SOPs on the RSPP website.
By checking this box, you agree to abide by the IRBsSOPs.
3 / Aurora IRB oversight (or appropriate deferral of IRB oversight) of all human subject research conducted at Aurora Health Care / … Agree to submit the research study to the Aurora IRB as outlined in Aurora RSPP SOP 301, or follow the procedure to request deferral of IRB oversight as outlined in Aurora RSPP SOP 409.
By checking this box, you are agreeing to this requirement.
4 / Research Administrative Pre-Authorization (RAP) / … Agree to submit a request to the Aurora Research Institute for Research Administrative Pre-Authorization (RAP) prior to submission to the Aurora RSPP office.
By checking this box, you are agreeing to this requirement.
5 / Agree to submit to ARI Research Business Services all contracts and agreements from sponsors. / … Agree to contact the ARI Research Business Services with any sponsor contracts or agreements related to the research.
By checking this box, you are agreeing to this requirement.
6 / Agree to abide by the Aurora IRB Conflict of Interest Policy RSPP SOP 104 and Aurora System Policy 200. / … All key personnel must complete, per policy, an annual Significant Interest Disclosure Statement in COI-Smart. New Significant Interest Disclosures must be reported in COI-Smart within 30 days of discovery.
By checking this box, you are agreeing to this requirement.
Section III: Attestations and Signature
- I certify that the information I have submitted in this application is true, accurate and correct.
- I understand that if it is determined that the information submitted by me was incorrect, false or intentionally misleading, or if I fail to follow any of the agreements or certifications I make in this application, the IRB can either deny granting me the right to conduct human subject research or revoke my rights to conduct human subject research.
- I understand that the Aurora IRB alone has full authority to allowkey personnel to conduct human subject research at Aurora Health Care, Inc.
- I further understand that the IRB alone provides me with an appeal process for denial, suspension or withdrawal of any rights associated with the conduct of human subject research.
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SignatureDate
Page 1 of 2Human Subjects Research Certification -- Renewal Application
Version 7/17
Scan the completed and signed application and send as an email attachment tothe Aurora IRB Office.
If you are unable to scan the application and attach it to an email, please call the Aurora RSPP office (414-219-7744)for further instruction.
Office use only
Right to conduct human subject research __ GRANTED__ DENIED
Renewal Due (Month/Year)______
Page 1 of 2Human Subjects Research Certification -- Renewal Application
Version 7/17