Schedule and Agenda

Breaking the Barriers of Research: Mentoring and Human Subjects' Protection

Day 1

0700-0800 Registration and Breakfast

0800-0815 WELCOME-
Brooks Gentry, MD, Vice-Chair for Research, Department of Anesthesiology
E. Albert Reece, MD, PhD, MBA, Vice Chancellor, UAMS, and Dean of the College of Medicine

0815-0820 INTRODUCTION
L.D. Milne, PhD, Vice Chancellor for Academic Affairs and Research Administration, UAMS will introduce Timothy Martin, MD, MBA

0820-0900 Keynote Speaker
Timothy Martin, MD, MBA,
Arkansas Children's Hospital, Department of Anesthesiology, Vice-Chair for Education and Administration
The Who, What, Why, When, and How of the Research Mentoring Process

Dr. Martin will discuss the challenges of the Research Mentoring Process and the responsibilities of Mentors and Trainees.

0900-0930 Dr. E. Haavi Morreim, PhD
Professor, Human Values and Ethics, University of Tennessee College of Medicine
How to Mentor Ethical Behavior

Dr. Morreim will address the process of mentoring researchers in performing ethical research.

0930-1000 Robin Harris, PhD
Professor, Georgia College & State University; Professor, GEM (Georgian Education Mentorship
Lessons learned during Mentoring Program Development for Students

Dr. Harris directs a comprehensive mentoring program for undergraduate students. She will discuss her experiences and share success and strategies for successful monitoring program development.

1000-1030 Jan Shorey II, MD UAMS Associate Dean of CME and Faculty Affairs
Glenda Cooper, MA, Director UAMS Faculty Affairs
Mentoring Physicians - Program Development and Implementation

Dr. Shorey and Ms. Cooper will be speaking on the UAMS mentoring program for women faculty members within the Faculty Affairs Department.

1030-1100 BREAK

1100-1145 Panel
Mentoring Success Tips for the Behavioral Researcher

Louanne Lawson, RN, PhD, FAAN, UAMS College of Nursing, Editor on Forensic Medicine Journal
Dana Gonzales, PhD , MHSA Instructor, UAMS College of Public Health
Warren Bickel, PhD, Director, UAMS Center for Addiction Research

This panel will address issues such as mentoring research staff in the field; data collection and the education of clinical coordinators for social science/behavioral research. Time will be available for questions and interaction from the audience.

1145-1230 Edgar Garcia-Rill, PhD
Director, UAMS Center for Translational Neuroscience
The Effects of a Successful Mentoring Program

Dr. Garcia-Rill will discuss the outcomes of his experiences with mentoring. He will outline monitoring of his mentoring program and indicate the benefits of mentoring to the researcher and the study.

1230-1330 LUNCH

1330-1400 David Wright, PhD, Consultant, Office of Research Integrity
An analysis of Misconduct Cases that involved Graduate Students and PostDocs

Dr. Wright will describe ORI misconduct cases and how lack of supervision has often played a role in contributing to misconduct.

1400-1430 Sandra Titus, PhD, Director, Intramural Research, Office of Research Integrity
Research Integrity Methods Reported by 3000 Principal Investigators

Dr. Titus will focus on the supervision and mentoring described by 3000 NIH extramural investigators, including an emerging trend that mentors refer to as "absentee mentoring."

1430-1500 Danna Carver, BSN, RN
Director, UAMS Office of Research Compliance
Mentoring for Compliance

Ms. Carver will discuss the Essential Elements of Compliance Training for Mentors including the nine core areas of Responsible Conduct of Research.

1500-1530-BREAK

1530-1615 Panel: Mentoring Success Tips for the Biomedical Researcher

Mentoring for Regulatory Compliance, Linda Wood, RN, BSN, CCRP Manager Clinical Research Division, UAMS Department of Otolaryngology

Mentoring for Study Subject Recruitment, Julia Washam, RN, UAMS Office of Clinical Trials

Mentoring Non-Research Nurses to Collect Research Data, Lisa Jackson, RN, Research Nurse, UAMS Myeloma Institute for Research and Therapy

Mentoring Coordinators/Data Managers for Study Management, Angie Allred, Director of Clinical Operations, Arkansas Research Medical Testing, LLC

Coordinators Responsibilities Regarding the Education of Inpatient Staff Members on Caring for Research Participants as Patients
Kimberly Polner, RN, JD, Research Associate, UAMS Department of Anesthesiology

1615-1645 Breaking the Barriers
Questions developed prior to the conference by UAMS in-house conference planners; will attempt to have electronic keyboards set up; will ask questions and have the audience answer; answers will be anonymous and the percentage of each of the answers chosen will be projected; answers will be reviewed and discussed.

1645-1700 EVALUATIONS & RAFFLE

1800-2100 Clinton Library "Getting to Know Reception." All conference faculty and participants are invited to attend a wine and cheese reception and tour the library at their leisure.

Day 2

0700-0800 Registration and Breakfast

0800-0815 Welcome
L.D. Milne, PhD, UAMS Vice Chancellor for Academic Affairs and Research Administration

0815-0915 Keynote Speaker
Why are we here and how did we get here?
Dale Hammerschmidt MD, FACP Director of Education in Human Subjects Protection, University of Minnesota

Dr. Hammerschmidt will discuss the historical to modern perspectives of Human Subject Protection, why it is such a necessity, and the importance of ensuring that team members are adequately and properly trained. He will also entertain the notion of how research history might have been different if mentoring had been in place.

0915-1000 Lesson Learned: Enlightening Experiences
David C. Clark, PhD, Director and Associate Vice Provost, Research Compliance, Rush University

Dr. Clark will discuss his reflections of the impact and institutional changes that occurred when Rush University research was suspended by OPRR (now OHRP).

1000-1025 BREAK

1025-1030 INTRODUCTION
L.D. Milne, PhD, UAMS Vice Chancellor for Academic Affairs and Research Administration, will introduce Bernard A. Schwetz, DVM, PhD

1030-1100 Current State of the Research Enterprise - OHRP Update
Bernard A. Schwetz, DVM, PhD
Director, Office for Human Research Protections

Dr. Schwetz will discuss the current activities of OHRP, compliance strategies and latest OHRP initiative.

1100-1130 A Consultant's Perspective: Will the FDA think you have good clinical data?
Michael Hamrell, PhD
President, MORIAH Consultants
(not affiliated with the FDA)

Dr. Hamrell will discuss the role of the FDA oversight Program in Detecting and Deterring Misconduct and Questionable Research Practices in Clinical Trials.

1130-1200 The Role of the IRB in Human Subject Protection
Jimmie Valentine, PhD, UAMS Professor of Pediatrics and Pharmacology,
UAMS Biomedical IRB Chairperson

The IRB plays a key role in protecting subjects. Dr. Valentine will outline that role and emphasize the IRB/investigator team relationship.

1200-1230 HSP and Therapeutic Misconception with a Focus on Investigator Initiated Treatment Trials
Felix Gyi, PharmD, MBA, CIP CEO Chesapeake Research Review, INC

Dr. Gyi will focus on the ways therapeutic misconception can affect human subject protection. He will elaborate on how this is especially problematic in investigator-initiated or sponsor/investigator studies.

1230-1330 LUNCH

1335-1400 Vulnerable Populations
Susan Delano, CIP, Deputy Managing Director, Research Foundation for Mental Hygiene, Inc

Ms. Delano will give an overview on the protection of vulnerable populations in general and discuss how she accomplishes this in her professional role.

1400-1500 Panel: How to Ensure the Protection of Vulnerable Populations

Susan Delano, CIP, Deputy Managing Director, Research Foundation for Mental Hygiene, Inc
Children and Vulnerable Populations

Judith Brooks, RN, MS, OHRP Representative
Regulations, OHRP and Secretary's Advisory Committee on Human Research Protections (SACHRP)

Jill Brackenbury, UAMS IRB Behavioral Chair
Financially Disadvantaged Populations

Kathy Richards, PhD, RN, UAMS Professor, College of Nursing
Cognitively Impaired Populations

1500-1530 BREAK

1530-1600 OHRP Answer questions from pre-conference questonnaires.

1600-1645 Panel: How to Educate IRB Members and Quality Improvement

Felix Gyi, PharmD, MBA, CIP, Chesapeake Research Review, INC

Dr. Gyi will speak about educational activities at Chesapeake Research Review, Inc., and what types of educational activities it had in place in order to obtain IRB certification.

Shirley Hicks, RN, CIP,OHRP, Director, Division of Education & Development

Ms. Hicks will speak about Quality Improvement processes necessary for IRBs.

Susan Delano, CIP Deputy Managing Director, Research Foundation for Mental Hygiene, Inc.

Ms. Delano will address CIP certifications for IRB professionals and answer questions about the CIP program. Ms. Delano is the Chair of the Council for Certification of IRB Professionals, and a charter member as well.

1645-1700 EVALUATIONS & RAFFLE