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OHRP Research Community Forum

The Office for Human Research Protections (OHRP) Research Community Forum (RCF) is hosted by Oakland University and Beaumont Health System. The RCF is a comprehensive one-day program focusing on regulatory and ethical issues in protecting human participants in research.  The theme of this program is "Strategies for Optimizing Human Research Protections" within the dynamic and complex milieu of regulatory, institutional, investigator, and other stakeholders' requirements and concerns. 

  • IRB members, administrators and staff
  • Institutional officials
  • Legal counsel staff
  • Public health officials
  • Principal investigators and research personnel
  • Human subject protection professionals
  • Patient and participation advocates
  • Privacy and compliance officers
Beaumont Health System OHRP logo
WELCOME
2013 SPEAKERS
PRESENTATION
MATERIAL
2013
PROGRAM
CONTINUING
EDUCATION
VIDEOS

Dear Attendees:

Welcome to the OHRP Research Community Forum, hosted by Oakland University and Beaumont Health System at the Oakland Center in Rochester, MI. It is an honor to be able to bring together experts from the Office for Human Research Protections (OHRP) and other federal agencies, as well as experienced IRB members, administrators and researchers to talk about “Strategies for Optimizing the Protection of Human Research Participants.” The members of the Conference Steering Committee extend a warm welcome and their best wishes for a rewarding day among colleagues in this critically important area of research ethics.

The main objective of this forum is to examine the range of considerations that each institution, IRB and members of the research community must make in order to ensure the optimal protections for people who generously agree to participate in research studies. We anticipate that the unique mix of federal officials, IRB experts, researchers and staff will encourage a synergy of ideas and viewpoints that will leave us all with a fresh commitment to the ethical conduct of human research studies. A secondary objective is to provide a means of networking with the research community at multiple levels, in small and large groups, and in a variety of learning contexts. We start with a keynote address from Dr. Joseph Gibbons on the crucial role of the principal investigator in human research protection programs. The plenary session will feature Elyse Summers JD, director of OHRP’s Division of Education and Development, who will provide an overview of OHRP guidance and activities. Twelve breakout sessions during the day cover a wide range of topics from which to choose. The “Ask the Feds” panel will wrap up the conference proceedings, and then we invite you to “meet and mingle” as you end your exciting day.

We extend our gratitude to our speakers, and to the dedicated team members whose efforts made this forum possible. We are also indebted to Dr. Susan Awbrey, Interim Senior Vice President for Academic Affairs and Provost of Oakland University, for her support of this initiative. We are especially grateful to OHRP for sponsoring this unique program, and providing the opportunity for all of us to meet and renew our commitment to human research protections. We look forward to meeting all of you, and hope you enjoy your experience.

Sincerely,




Dorothy A. Nelson, PhD.
Vice Provost for Research
Office of Research Administration
Oakland University

David L. Felten, M.D., PhD.
Vice President for Research and
Medical Director, Research Institute
Beaumont Health System

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Keynote Speaker

Joseph Gibbons, MD - Case Western Reserve University
Dr. Gibbons is a hematologist-oncologist at University Hospitals Seidman Cancer Center and assistant professor of Medicine at Case Western Reserve University School of Medicine. He is the chairperson of the University Hospitals Institutional Review Board. Dr. Gibbons’ research interests include cancer clinical trials and applied research ethics. He is an active member of the Phase I Drug Development Program at the Seidman Cancer Center. A graduate of Hiram College and the Ohio State University College of Medicine, Dr. Gibbons completed his internal medicine residency at the University of Toledo and his specialty training at the University of Michigan and the University of Alabama. Dr. Gibbons is a member of Public Responsibility in Medicine and Research, the American Society of Hematology, the American Society for Clinical Oncology, and the American Medical Association.

Edward E. Bartlett, PhD - Office for Human Research Protections (OHRP)
Dr. Ed Bartlett received his undergraduate degree in the behavioral sciences from Ohio University, his Master of Public Health degree from the University of Illinois at Chicago, and his doctorate from Johns Hopkins University.

He was an assistant professor in the School of Public Health at the University of Alabama at Birmingham for six years. He was the editor-in-chief of Patient Education and Counseling journal for eight years. He has published over 100 scholarly articles on informed consent, confidentiality, and other topics.

Dr. Bartlett previously was the administrator and member of an IRB at a tertiary care medical center in Washington, DC. Since 2003, he has served as the International Human Research Liaison at the Office for Human Research Protections.

Nancy Bellamy - Consumer Safety Office, Food and Drug Administration, Detroit District Office
Nancy Bellamy is a bioresearch specialist in the Detroit District Office. She is the BIMO coordinator for the district, and tracks assignments from headquarters for BIMO inspections in Michigan and Indiana. Mrs. Bellamy graduated from Mercy College in Detroit and started her career in FDA’s Chicago District. Later, she spent four years in the Saginaw, Michigan FDA Resident Post and transferred to the Detroit District office. She is active in the International Inspection cadre and has traveled to many interesting parts of the world on BIMO inspections, including Egypt, Europe, China, India, South Africa, Zambia and South America.

Elizabeth Buchanan, PhD - University of Wisconsin-Stout, Center for Applied Ethics
Dr. Elizabeth Buchanan is endowed chair in ethics and director of the Center for Applied Ethics at the University of Wisconsin-Stout. She is a scholar in the fields of research ethics, information/communication technology ethics, and research methods. Her work is particularly focused on the intersections of research regulation, internet or online venues and tools, and the subsequent ethical challenges that arise for researchers and research board reviewers. She is professionally active in Public Responsibility in Medicine and Research, the International Society for Ethics and Information Technology (Co-Director), and the Association of Internet Researchers. Elizabeth serves as an associate editor for the Journal of Research on Human Research Ethics (JERHRE), on the Editorial Boards of the International Review of Information Ethics and Philosophy and Technology, and reviews for many other scholarly journals and granting agencies.

Dr. Buchanan currently serves on the UW Stout's Institutional Review Board, and has served on both social science and medical school research ethics boards, and has presented her National Science Foundation-funded research on IRBs and Internet research to the Secretary's Advisory Committee to the Office for Human Research Protections in 2010 and 2012.

Kristin Burt, JD - Community Research Institutional Review Board (CRIRB), Michigan State University
Kristen Burt, J.D., is the interim director of the Michigan State University Human Research Protection Program (HRPP). Joining the MSU Institutional Review Board office in 2001, she has performed case management of human research projects, has led MSU’s application processes to AAHRPP, Inc., and coordinated IRB education programs. Ms. Burt currently leads policy and planning initiatives within the Office of Regulatory Affairs and is presently serving as the director of the HRPP. Kristen Burt obtained a Bachelor of Science in Human Biology and a Bachelor of Arts in General Business Administration from Michigan State University (MSU) and a Juris Doctor from the MSU College of Law.
Rozelle Copeland, PhD - Associate Director, IRB Administration, Wayne State University

Dr. Copeland
Dr. Copeland is the associate director of IRB Administration at Wayne State University, which has five IRBs. She has experience with regulatory compliance, developing resources for IRBs, policies, processes, forms, and the administration of IRBs. Dr. Copeland also serves as a consultant in continuous quality improvement and program development and evaluation for mental healthcare provider companies. Dr. Copeland has over 25 years of experience in the mental health field, experience with programs for juvenile justice, and has been a research investigator at Wayne State University. Dr. Copeland is the co-author of a book on autism and co-author of two transition planning assessment tools for persons with cognitive and developmental disabilities.

Linda Darga, PhD - Grant Development Specialist, Office of Research Administration, Oakland University
Linda Darga has a PhD in Biological Anthropology from Wayne State University. She had a three-year NIH Research Fellowship at Children’s Hospital of Michigan and then conducted research at the Beaumont Weight Loss Clinic with numerous publications in weight loss and its physiological correlates and also worked with drug studies conducted at the clinic. She then conducted studies at the Karmanos Cancer Institute and Wayne State University in breast cancer and prostate cancer. She also held positions in Oncology at Children’s Hospital and Karmanos working with clinical trials. She has taught many years, both undergraduate and graduate courses in anthropology at Wayne State University, Oakland University, and the University of Windsor.

Michael P. Diamond, MD - OB-GYN Chair, Medical College of Georgia, VP for Clinical and Translational Science, Georgia Regents University-Augusta
Michael P. Diamond, MD, is the Brooks professor and chair of the Department of Obstetrics & Gynecology, associate dean for Research of the Medical College of Georgia, and vice president for Clinical and Translational Science at Georgia Regents University Augusta. Prior to his current appointment, Dr. Diamond was Kamran S. Moghissi professor and associate Chair of the Department of Obstetrics and Gynecology, and assistant dean for Clinical and Translational Research at Wayne State University School of Medicine in Detroit, Michigan. He is an internationally renowned clinical and translational investigator, who is recognized for many scientific contributions, including within the field of Reproductive Endocrinology and Infertility.

Dr. Diamond has been funded by six NIH Institutes, including NICHD to conduct randomized clinical trials utilizing the euglycemic, hyperinsulinemic clamp and hyperglycemic clamp techniques to evaluate the role of androgens on insulin sensitivity in men and women. He also served as WSU’s PI on the NICHD Cooperative Reproductive Medicine Network grant, which has conducted clinical trials on diagnosis of luteal phase defects, ovulation induction for women with polycystic ovarian syndrome, and ovarian stimulation for unexplained infertility.

Jaci Goldberg, JD - National Cancer Institute (NCI), Central Institutional Review Board Initiatives
Jacquelyn L. Goldberg, JD, is currently at the National Institutes of Health, where she is the head of the National Cancer Institute's Central IRB Initiative. Prior to joining the federal government, she worked at the University of Missouri-Columbia as the compliance officer for the Health Sciences IRB and as an adjunct professor in the School of Nursing focusing on ethics in clinical research. While at the University, she was also involved in post-conflict health and development issues in Bosnia through the University's International Center for Psychosocial Trauma and co-taught a university-wide undergraduate course on women's issues in global health. In addition to her expertise in the ethical and regulatory aspects of biomedical research, she has extensive program and policy experience in women’s health, hospital risk management, and community health planning. She is a graduate of Brandeis University and Antioch School of Law.

Barbara Higgins, BSN - Research Education Manager, Research Institute, Beaumont Health System
Barbara Higgins has been the research education manager for Beaumont's Research Institute for over ten years. She plans and provides educational offerings, auditing services and also participates in policy development. Her educational background includes a Bachelor of Science in Nursing from the University of Western Ontario, and her experience as a nurse, study coordinator, and educator have given her a comprehensive base from which to approach many topics.

Stuart Horowitz, PhD, MBA - Managing Director, Western Institutional Review Board
Stuart Horowitz, MBA, PhD, serves as president, Institutions and Institutional Services at WIRB-Copernicus Group. In this role, Dr. Horowitz is responsible for WIRB-Copernicus Group's consulting services, Institutional Biosafety Committees, Data and Safety Monitoring Services and international services. Dr. Horowitz holds a PhD in cell and molecular biology. He has focused his career on the growth and success of institutional clinical research enterprises. Dr. Horowitz has held leadership positions within institutions, at the CardioPulmonary Research Institute at Winthrop-University Hospital (NY), the Center for Advanced Medicine at Jewish Hospital (Louisville, KY) and the Miami Children's Hospital Research Institute (FL). As a consultant, Dr. Horowitz has advised scores of research-intensive organizations in the U.S. and the Middle East, assisting in the creation and growth of laboratory and clinical research programs. Dr. Horowitz earned his Bachelor of Arts degree from the State University of New York at Binghamton, his PhD in Biology from the University of Rochester, and his Executive MBA from Bellarmine University.

John M. Koerber, PharmD - Beaumont Health System
Dr. Koerber received his Bachelors of Science Degree from Wayne State University in Detroit, Michigan and his Doctorate of Pharmacy Degree from the University of Florida in Gainesville, Florida. He completed a general practice pharmacy residency at Beaumont Hospital, Royal Oak. Dr. Koerber is currently the coordinator for the Investigational Drug Service at Beaumont Health System. He has been a member of the Beaumont Health System Human Investigation Committee (Institutional Review Board) for over eight years and is currently serving as the chairperson (past four years). Dr. Koerber is a member of Public Responsibility in Medicine and Research and the American College of Clinical Pharmacy.

Gayle Kusch, MSA - Wayne State University
Gayle Kusch is the senior director for Compliance at Wayne State University’s Research Compliance Office, where she directs the operational and regulatory activities associated with the human and animal protection programs, financial conflict of interest, export control, and research misconduct. A lifelong Michigan resident and a graduate of both University of Michigan–Dearborn and Central Michigan University, she has been involved in the research enterprise her entire career. Prior to the oversight of regulatory areas impacting research, she worked as the manager for the clinical trials office at the Meyer L. Prentis Comprehensive Cancer Center (now Karmanos), and was the project director for the National Heart, Lung, and Blood Institute’s Women’s Health Initiative – Detroit Clinical Center.


Barbara Scott, MHSA - Beaumont Health System
Barbara Scott, MHSA, CCRP, CRHC, is the director of Research Regulatory and billing at Beaumont Health System, coordinating compliance activities for the Research Institute. Among her other responsibilities, Ms. Scott is the administrator of the research conflict of interest program at Beaumont, as well as co-chair of the Research Conflict of Interest Committee. She earned a Bachelor's of Science degree in Management from Oakland University and a Masters of Health Services Administration from Central Michigan University. Prior to joining Beaumont in 2000, Ms. Scott held various management positions in retail finance and accounting.

Robyn Shapiro, JD - Drinker Biddle & Reath LLP, Milwaukee Office
Robyn S. Shapiro, JD, health law partner and Regional Partner in Charge in the Milwaukee office of Drinker Biddle & Reath LLP, has significant experience with respect to bioethics issues, research compliance issues, medical staff matters, health information privacy issues, informed consent, and regulatory and licensing matters. Attorney Shapiro's position as Ursula von Der Ruhr Professor of Bioethics at the Medical College of Wisconsin, and 26-year leadership as director of the Center for the Study of Bioethics, complement her wide-ranging experience in health law. Ms. Shapiro is listed in the Best Lawyers in America, Who's Who in American Law, Who's Who in America, Who's Who of American Women, Who's Who of Emerging Leaders of America, Who's Who in the Midwest, International Who's Who, Who's Who in the World, Who's Who in American Education, and Wisconsin Super Lawyers; she was included in Nightingale's 2006 list of "Outstanding Hospital Lawyers" in the nation; in 2006 she was one of 12 honorees selected as "Leader in the Law" by the Wisconsin Law Journal and in 2011 was named "Woman of Influence” by the Milwaukee Business Journal and Milwaukee's Health Care "Lawyer of the Year" by Best Lawyers.

Christine Stiller, PhD - School of Health Sciences, Oakland University
Christine Stiller received her bachelor’s degree from Wayne State University in 1976, a master’s degree in Human Development from Wayne State University in 1982, and a PhD in Educational Psychology from Michigan State University in 1998. She has been a special instructor in the Physical Therapy Program at Oakland University since 1982, where she teaches both entry-level and post entry-level courses related to pediatrics, education, psychosocial aspects of patient management, and research methodology. As a pediatric physical therapist, she has worked in medical, educational, outpatient and home care settings. Dr. Stiller currently has a pediatric private practice through which she provides therapy services to schools in the Detroit Metropolitan area. She has conducted research in pediatric physical therapy and physical therapy education. Dr. Stiller has been a member of the Oakland University Institutional Review Board for approximately 15 years and is currently the chair of the Oakland University IRB.

Elyse I. Summers, JD - Office of Human Research Protections (OHRP)
Elyse I. Summers, JD, has been with the Office for Human Research Protections since 1998. Since 2008, she has been the director of OHRP’s Division of Education and Development. Prior to that, Ms. Summers practiced law with Buc & Beardsley in Washington, DC, where her work involved the law of food, drugs, and other medical products, and included providing guidance and counseling on Federal regulations and ethical issues related to the conduct of biomedical research. Before Buc & Beardsley, Ms. Summers spent five years in the Office of the Commissioner at FDA. Ms. Summers also practiced the law of tax-exempt organizations at Steptoe & Johnson, and Baker & Hostetler, respectively. She began her professional career representing research universities at the Association of American Universities. She received her JD from George Washington University and her BA from the University of Michigan. Ms. Summers holds bar membership in Washington, DC and Pennsylvania.

Linda Triemer, PhD - retired Van Andel Research Institute
Dr. Triemer retired in 2012 as the director of the Compliance Office at the Van Andel Research Institute (VARI), an independent research and education institute that focuses on biomedical translational science. She had oversight of the IRB and was a site-visitor for the Association for Accreditation of Human Research Protection Programs (AAHRPP). Prior to her work at VARI, she had similar roles at the University of Chicago, director of Research Integrity, and Michigan State University, Director of the Office of Regulatory Affairs. Dr. Triemer’s research spanned academic, private and non-profit institutions specializing in human health risk assessment, and use of medical records to assess the quality and provision of health care for special populations. She obtained her PhD in Public Health Sciences at the University of Illinois at Chicago, and post-doctoral training in Epidemiology at the Chemical Industry Institute of Toxicology.

Corey Zolondek, PhD - IRB Specialist, Office of Research Administration, Wayne State University
Corey Zolondek has served as a research subject advocate in Wayne State University’s Division of Research since October 2010. He assists research participants with questions related to volunteering, provides guidance to researchers and staff on the informed consent process, performs community outreach, and reviews the use of medical records in research studies. Until recently, Dr. Zolondek served as an IRB Specialist at Oakland University, where he provided administrative support in the review of research applications.

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  • KEYNOTE ADDRESS:  Investigator Responsibilities in FDA Regulated Research - Joseph Gibbons, MD



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      Time Activity
      7:30 - 8:30 am Breakfast and Registration
      8:30 - 8:45 am
      Banquet Room
      Welcome and Introduction: Dorothy Nelson, PhD (Oakland University) and David Felten, MD, PhD (Beaumont Health System)
      8:45 - 9:45 am
      Banquet Room
      Keynote Address - PI Responsibilities:  Joseph Gibbons, MD (Case Western Reserve)
      Dr. Gibbons will describe the crucial role of principal investigators (PI) in protecting the rights and welfare of human participants in research. He will provide an overview of the PI’s responsibilities and ongoing requirements for the responsible conduct of human subjects research.
      9:45 - 10:30 am
      Banquet Room
      Plenary Session - OHRP Update: Elyse I. Summers, JD, (Office for Human Research Protections)
      This session will provide a basic introduction to, and update on, OHRP guidance and activities.
      10:30 - 11:00 am Break and Exhibits (refreshments)
      11:00 am - 12:15 pm

      Break-out 
      Session 1
      Gold Room C
      1A: Alternative IRB Models 15 minutes each, with Q&A 

      Elyse I. Summers, JD (OHRP) -- Intro 
      Michael Diamond, MD (GRU)
      Jaci Goldberg, JD (NCI CIRB)
      Kristin Burt, JD (MSU CRIRB) 
      Stuart Horowitz, PhD (MBA, WIRB)

      Gold Room A

      1B: Working with Students-- as investigators, as participants, and in classroom research 

      Christine Stiller, PhD (OU)




      Room 126-127

      1C: International Research: Preparing for your Next Safari 

      Edward E. Bartlett, PhD (OHRP)





      Oakland Room

      1D: Best Practices for IRB Chairs and IRB Members 

      Joseph Gibbons, MD (Case Western Reserve)
      John Koerber, PharmD (BHS) 
      Robyn Shapiro, JD (Drinker Biddle & Reath)
      Linda Triemer, PhD (retired, van Andel Research Institute)
      12:15 - 1:00 pm
      Cafeteria
      with Table Topics
      Lunch:  Open seating (limited) with 6 tables reserved for special topics
      1:00 - 2:00 pm

      Break-out 
      Session 2
      Gold Room A

      2A: What do Participants Understand? Informed Consent and the Research Subject Advocate 

      Corey Zolondek, PhD (WSU)
      Research Participants
      Room 126-127

      2B: Planning for the Unexpected - Part 1: Cognitively Impaired Subjects 

      Robyn Shapiro, JD (Drinker Biddle & Reath)
      Oakland Room

      2C: Data Security, Confidentiality, and Privacy — Part 1: Social Media and New Technologies 

      Elizabeth Buchanan, PhD (UW-Stout)
      Gold Room C

      2D: Audits: Making it Work for Everyone—Part 1: The IRB 

      Nancy A. Bellamy (FDA)
      Elyse I. Summers, JD (OHRP)


      2:00 - 2:30 p.m. Break and Exhibits (refreshments)
      2:30 - 3:30 pm

      Break-out 
      Session 3
      Gold Room A

      3A: Facilitating Compliance with IRB and FCOI Requirements 

      Gayle Kusch, MSA, (WSU) 
      Linda Darga, PhD (OU) 
      Barbara Scott, MHSA (BHS)







      Gold Room C

      3B: Planning for the Unexpected - Part 2: Prisoners, Employees, and Non-English Speakers 

      Rozelle Copeland, PhD (WSU) 
      Barbara Higgins, BSN (BHS) 
      Robyn Shapiro, JD (Drinker Biddle & Reath)
      Edward E. Bartlett, PhD (OHRP)


      Oakland Room

      3C: Data Security, Confidentiality, and Privacy—Part 2:  Internet Research

      Elizabeth Buchanan, PhD (UW-Stout)








      Room 126-127

      3D: Audits: Making it Work for Everyone — Part 2: The Investigator 

      Nancy A. Bellamy (FDA)









      3:30 - 3:45 p.m. Break
      3:45 - 4:45 pm
      Banquet Room
      Ask the Feds Panel (Federal agency representatives)
      In this session, the audience will be able to address questions to the federal agency representatives about human research protections regulations, IRBs, and other areas of interest.
      4:45 - 5:00 pm
      Banquet Room
      Wrap-up
      5:00 - 5:45 pm
      Cafeteria
      Meet and greet mixer at Oakland Center (light refreshments)

      Break-Out Descriptions

      BREAK-OUT SESSION 1 - 11:00 a.m. to 12:15 p.m.

       1A: Alternative IRB Models - Gold Room C

      Elyse I. Summers, JD, Office for Human Research Protections
      Michael Diamond, MD, Medical College of Georgia, Georgia Regents University
      Jaci Goldberg, JD, National Cancer Institute, Central IRB Ethics
      Kristin Burt, JD, Michigan State University, Community Research Institutional Review Board
      Stuart Horowitz, PhD, MBA, Western IRB
      In this session, the presenters will provide descriptions of several types of IRBs that vary from the conventional university or hospital-based models to alternative models to facilitate specialized needs. These include the National Cancer Institute’s central IRB, a university IRB that reviews only phase I clinical trials, a community IRB that serves as the IRB of record for a university and its community partners, and an overview of independent and/or commercial IRBs.

      1B: Working with Students - as investigators, as participants, and in classroom research - Gold Room A
      Christine Stiller, PhD, Oakland University
      When students are learning to conduct research as independent investigators, they may find it difficult to understand and navigate the IRB process. Their role in research is further complicated when they serve as research participants themselves and may have vulnerabilities, which merit extra protections. In this session, Dr. Stiller will explore the issues and some possible approaches to these challenges, as well as considerations that IRBs must make when evaluating planned classroom research.

      1C: International Research: Preparing for your Next Safari - Room 126-127
      Edward E. Bartlett, PhD, Office for Human Research Protections
      This session will be led by Dr. Edward E. Bartlett, the International Human Research Liaison for the Office for Human Research Protections. He will discuss approaches to ensuring that human research participants outside of the United States, who enroll in research projects, receive the same level of protection as research participants inside the United States. He will also provide information on the assistance that OHRP offers for human research protections in international research.

      1D: Best Practices for IRB Chairs and IRB members (includes succession planning and IRB mission creep) - Oakland Room
      Joseph Gibbons, MD, Case Western Reserve
      John Koerber, PharmD, Beaumont Health System
      Robyn Shapiro, JD, Drinker Biddle & Reath LLP, Milwaukee Office
      Linda Triemer, PhD (retired, van Andel Research Institute)
      The presenters in this session are experienced IRB chairs, members, and IRB compliance experts. They will discuss best practices for IRB members and administrators, including reducing IRB “creep” and aspects of succession planning for members and staff. Questions from the audience are welcome.

      BREAK-OUT SESSION 2 -1:00 p.m. to 2:00 p.m

      2A: What do Participants Understand? Informed Consent and the Research Subject Advocate - Gold Room A
      Corey Zolondek, PhD, Wayne State University
      In this session, Dr. Zolondek, an experienced Research Subject Advocate, will discuss the role of the informed consent process in protecting human research participants. He will also moderate a discussion among several research participants about their experiences.

      2B: Planning for the Unexpected-- Part 1: Cognitively Impaired Subjects - Room 126-127
      Robyn Shapiro, JD, Drinker Biddle & Reath LLP, Milwaukee Office
      It is important to recognize and afford appropriate protections to research participants with cognitive impairments that may affect their ability to make decisions for themselves. This session will explore approaches to identifying and protecting these participants, especially when a research study is not designed to accommodate this special class of research subjects.

      2C: Data Security, Confidentiality, Privacy—Part 1: Social Media and New Technologies - Oakland Room
      Elizabeth Buchanan, PhD, University of Wisconsin-Stout
      Dr. Buchanan will discuss ethical issues in emergent forms of online human subjects research, including the use of social media and other technologies. She will suggest approaches to IRB review practices and procedures with regard to internet research.

      2D: Audits: Making it Work for Everyone—Part 1: The IRB - Gold Room C
      Nancy A. Bellamy, Food and Drug Administration
      Elyse I. Summers, JD, Office for Human Research Protections
      In this session, attendees will be provided general information about audits of IRBs by OHRP or FDA, and the importance of working together to correct deficiencies and make improvements in the IRB program. The session will include tips on preparing for, and responding to, an IRB audit.

      BREAK-OUT SESSION 3 - 2:30 p.m. to 3:30 p.m

      3A: Facilitating Compliance with IRB and FCOI Requirements - Gold Room A
      Gayle Kusch, MSA, Wayne State University
      Linda Darga, PhD, Oakland University
      Barbara Scott, Research Institute, Beaumont Health System
      The new PHS regulations on financial conflict of interest add an additional layer of complexity in complying with human subjects research regulations. The presenters will discuss best practices for complying with these and other COI requirements that affect the IRB.

      3B: Planning for the Unexpected --Part 2: Prisoners, Employees, and Non-English Speakers - Gold Room C
      Rozelle Copeland PhD, Wayne State University
      Barbara Higgins, BSN, Beaumont Health System
      Robyn Shapiro, JD, Drinker Biddle & Reath LLP, Milwaukee Office
      Edward E. Bartlett, PhD, Office for Human Research Protections
      This session’s speakers will address three types of research participants who might unexpectedly present for enrollment in, or continued participation in, a research study that was not designed to accommodate them. The presenters will discuss the considerations that must be made and approaches to properly protecting these research participants.

      3C: Data Security, Confidentiality, Privacy—Part 2: Internet Research - Oakland Room
      Elizabeth Buchanan, PhD, University of Wisconsin-Stout
      Dr. Elizabeth Buchanan will discuss principles of confidentiality and privacy in human subjects research. She will also review issues related to data security, which is increasingly important when most data are now stored electronically and can be disseminated via the internet, with associated risks to human research protections.

      3D: Audits: Making it Work for Everyone —Part 2: The Investigator - Room 126-127
      Nancy Bellamy, Food and Drug Administration
      Michael Diamond, MD, Medical College of Georgia, Georgia Regents University
      Attendees will learn what to expect in an FDA audit of a protocol from the auditor’s and investigator’s perspectives. The audience is encouraged to ask questions.


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      Continuing Medical Education (CME)
      OHRP Research Community Forum 2013


      Statement of need

      This conference is designed to inform health care professionals about ethical, regulatory and policy issues and their own roles related to protecting participants in clinical research in order to conduct compliant and ethical research.

      Learner objectives
      1. Recognize the broad range of regulatory, ethical and policy issues related to research involving human subjects
      2. Examine strategies for optimizing the protection of human participants in research
      3. Identify their role in protection of human research participants in research
      Disclosure

      All speakers and members of the planning committee have been asked to disclose any significant relationships they may have with commercial companies. The presence or absence of relationships will be disclosed at the time of the meeting.

      Accreditation

      This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of William Beaumont Hospital, Oakland University and the Office of Human Research Protections. William Beaumont Hospital is accredited by the ACCME to provide continuing medical education for physicians.

      Credit Designation

      William Beaumont Hospital designates this live activity for a maximum of 6.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity

      Jointly sponsored by William Beaumont Hospital, Oakland University, and the Office for Human Research Protections.

      Certified IRB Professional (CIP)

      Conference sessions that meet the criteria in the Certified IRB Professional recertification guidelines are eligible for six (6) hours of CIP continuing education credits.


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      Elyse I. Summers, JD - Office of Human Research Protections (OHRP) 

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