1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. 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!

8. 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.

9. 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.

10. 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.

11. 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

12. 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.

13. 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.)

14. 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

15. 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

16. Tools and Templates Study Tools and Templates are located at:
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

17. 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

18. How to Report Concerns
Call the UAMS Office of Research Compliance at
Call the ACRI Research Compliance Director at
Call the UAMS Compliance Hotline at to report your concerns anonymously.

19. ORC Staff Contact Information
Darri Scalzo Carrie Chiaro
Research Compliance Officer Compliance Audit Manager
Phone#: Phone #: 
Nancy Rhea Jennifer McCluskey
Research Compliance Analyst Research Compliance Analyst
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Kimberly Murphy Catrice Banks-Johnson
Research Compliance Analyst Education Resource Specialist
Phone #: Phone #: