UAMS Office of Research Compliance The UAMS Office of Research Compliance (ORC) reports to the Vice Chancellor for Institutional Compliance, who in turn reports to the Chancellor and the Board of Trustees. We work closely with research, university and hospital administration, but are independent of them.

UAMS Office of Research Compliance The Office of Research Compliance (ORC) promotes the responsible conduct of research, the protection of human subjects, and the welfare of animals used in research. UAMS’s demonstrated commitment to compliance supports the institution’s ability to attract research support from industry sponsors and granting agencies and to minimize the inherent risks associated with conducting research.

Activities of the ORC Include Developing and presenting tailored educational programs about research requirements and best practices   Conducting reviews of and providing feedback regarding current human subject research activities and animal research activities; includes random and for cause reviews Responding to research compliance-related inquiries and concerns from investigators, their staff, the IRB, the IACUC, and UAMS administration

Activities of the ORC Include For studies conducted at both UAMS and ACH/ACRI, the ORC will work with ACRI staff to provide education, review studies, and respond to any compliance concerns. For studies conducted solely at ACH/ACRI, Margie Brackeen and Amanda Holloway will be your compliance contacts.

Human Subjects Study Reviews Routine reviews are full reviews of studies selected at random and focus on open studies with enrolled subjects. Requested reviews are full reviews conducted at PI request in order to obtain feedback after subject enrollment. Targeted/Directed reviews are full or focused reviews of studies after subject enrollment, in response to compliance problems or complaints, or at the request of the IRB. NICE reviews, as well as continuing assistance and ongoing education, are offered to investigators and their staff with regard to human subject research and compliance questions.

NICE Reviews Investigation Consult and Education New Investigation Consult and Education ORC established the NICE Review program to help investigators get a “jump start” on compliance: governmental and institutional rules and regulations pertaining to human subject research.

Purpose of NICE Reviews Get feedback on proposed study documentation and processes after IRB approval but before subject enrollment. Review/discuss assignment of responsibilities, recruitment and enrollment procedures, study methods and activities, and plans for study documentation of all study activities. Help identify potential problem areas before actual problems occur!

Reasons for a NICE Review Practical - Provides straightforward information and a list of specific (but informal) recommendations. Proactive - “Preventive care” for your research study, addressing and avoiding potential problems before they develop. Pro bono - Voluntary and available at no cost to investigators. Painless - Conducted based on your needs and within your timeframe. Turn around is typically very quick so you can get started with enrollment.

Reasons for a NICE Review NICE reviews are particularly helpful for: new investigators/coordinators of non-IND/IDE investigator- initiated research investigators of non-IND/IDE investigator-initiated research with no study coordinator anyone wanting assistance with study setup before enrollment begins anyone with questions about how to record data, IRB reporting requirements, etc.

Reasons for a NICE Review Industry sponsors frequently have very detailed protocols with many procedures/activities specified, yet often their case report forms do not contain a place to document all the protocol-required activities. A NICE review can help identify those areas where the sponsor CRF is lacking so that you can develop a means to document all protocol-required activities.

Reasons for a NICE Review During the NICE Review, ORC will provide: recommendations for set-up/organization of study records and required documents instruction concerning local IRB reporting requirements for: adverse events protocol deviations Amendments/modifications continuing review data safety and monitoring advice on the informed consent process and documentation clarification of confidentiality and HIPAA issues

NICE Review Process Pre-Meeting ORC will schedule meeting date/time with the study staff representative Will inform study staff of what to expect and what will be reviewed/discussed (protocol, consent form, HIPAA authorization, regulatory binder, advertisements, recruitment plan, case report forms, etc.) Will suggest study staff develop a list of questions or concerns they have ORC will perform a pre-meeting review of all study documents in CLARA ORC will create a discussion point list from what is discovered during our review.

NICE Review Process During Meeting Informal, open review/discussion (strictly help-oriented), working directly with research staff Review/discuss study file documents (protocol, ICF, CRFs, etc.), Review/discuss the consent process and study procedure plans with research staff Review regulatory binder setup/organization based on study type (e.g., Focus group study will not need section for Laboratory credentials, etc.)

NICE Review Process Meeting Conclusion Answer any additional questions Offer any suggestions/recommendations Provide research tools and regulatory document templates or web address for documents as needed No “official” findings report that will be shared with the IRB

Other Services Offered by ORC Consult on compliance issues Advise investigators, study staff, administration, the IRB Interact with oversight agencies when needed Educate researchers and staff

Tools and Templates Study Tools and Templates are located at: http://orc.uams.edu/regulatory-reference/tools-and-templates/ Designed to guide researchers through setting up their studies and conducting their own internal reviews Based on IRB Policies and ORC’s review procedures Also based on what we typically see in study reviews

Certified Research Specialist (CRS) Program The CRS Program provides essential training in key areas for individuals involved in, or interested in learning more about, research at UAMS and ACRI. Certified Research Specialists complete 28 hours of coursework and pass a comprehensive CRS Proficiency Exam. There is no charge for participating in the program. We present new and continuing Certified Research Specialists with their formal certificates at the annual CRS Awards Ceremony each January. For more information, please see http://orc.uams.edu/compliance-education-program/certified-research-specialist-program-crs/

How to Report Concerns Call the UAMS Office of Research Compliance at 686-8062. Call the ACRI Research Compliance Director at 364-3856 Call the UAMS Compliance Hotline at 1-888-511-3969 to report your concerns anonymously.

ORC Staff Contact Information Darri Scalzo Carrie Chiaro Research Compliance Officer Compliance Audit Manager Phone#: 686-8062 Phone #:  526-6270 Email: DLScalzo@uams.edu Email: ChiaroCarrieL@uams.edu Nancy Rhea Jennifer McCluskey Research Compliance Analyst Research Compliance Analyst Phone #:  686-5186 Phone #: 686-5809 Email: RheaNancyL@uams.edu Email: McCluskeyJenniferL@uams.edu Kimberly Murphy Catrice Banks-Johnson Research Compliance Analyst Education Resource Specialist Phone #: 686-6340 Phone #: 526-6879 Email: KJMurphy@uams.edu Email: CRBanksJohnson@uams.edu