OHRP Research Community Forum
Dates: March 29-30, 2023
Join us in Knoxville, Tennessee at the Crowne Plaza Hotel in Downtown, for a two-day, in-person Research Community Forum presented by the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), East Tennessee State University, Oak Ridge Associated Universities, and the University of Tennessee, Knoxville.
Day 1 will be led by OHRP and will provide an opportunity for small group and workshop discussions. This one-day Research Community Forum workshop combines didactic instruction and engaging interactions to help participants understand how to interpret and apply the U.S. federal regulations and policies on human research protections.
Day 2 will focus on the ethical aspects of conducting human subjects research, focusing on the emerging technologies with specific interest in artificial intelligence, biometrics, mobile health technology, and biosecurity.
The purpose of this program is to provide information to Institutional Review Board (IRB) members, IRB administrators, clinical investigators, research support staff, research sponsors, contract research organizations, government regulators, and members of the clinical research community about current issues regarding the protection of human subjects.
Registration for the Research Community Forum is available online.
Knoxville is a vibrant city home to the University of Tennessee and the World’s Fair Park and gateway to the Smoky Mountains, the most-visited national park in the United States. The downtown and Old City areas feature restaurants, eclectic shopping, a movie cinema, bookstore, riverfront park and nighttime entertainment.
A free downtown trolley will take you around town, or you can reach your destination by walking. Dining options range from an old-fashioned Southern breakfast to traditional favorites and international and fusion flavors.
Whatever your passion, Knoxville knows how to fuel it. Our ever-growing list of things to do includes everything from historical tours to outdoor adventure. Discover fine food, festivals, award-winning theatres and music for every ear. By visiting our nature-loving-adventure-seeking-artsy-kinda-town!
The Crowne Plaza Knoxville is located at 401 W Summit Hill Drive, Knoxville, TN 37902, in the heart of downtown Knoxville. Hotel room daily rates for conference attendees are $100 for two beds.
Reservations: Make your conference-hotel room reservations online. The GROUP CODE field will automatically populate with the group code, when their arrival and departure dates are entered. Cut-off day for discount rate is Monday, February 27, 2023.
Air travel to Knoxville: Five airlines serve the TYS destination. Visit TYS Airport to learn more.
Research in the Age of Technology – The Impact of Innovative and Emerging Technologies on Human Subjects Research
Proposed Agenda for Day 1 Forum Workshop
March 29, 2023
The one-day Research Community Forum Workshop provides an opportunity for the research community to engage directly with OHRP staff to explore important aspects of human research protections. Distinct from the Forum Conference, the Forum Workshop combines didactic instruction and engaging interactions to help participants understand how to interpret and apply the U.S. federal regulations and policies on human research protections.
Investigators conducting biomedical or socio-behavioral human subjects research, research coordinators, and key personnel involved with a human research protections program (HRPP) including institutional review board (IRB) chairs and reviewers, IRB administrators, and institutional officials.
Participants are expected to have a working knowledge of the HHS regulations on human research protections.
- Understand and apply the ethical principles of research and the HHS policies for human research protections when conducting research
- Recognize the expectations and requirements for the IRB review process and understand how to fulfill the responsibility of protecting the rights and welfare of research subjects
- Explore the operational and implementational challenges in supporting an adequate institutional framework for protecting research participants
Credit hours are awarded on an hour to hour (1:1) basis, meaning that every hour of classroom learning is equivalent to one continue education credit. Credits are quartered in .25 increments, meaning every 15 minutes is equal to .25 credit hour.
9:00 – 9:45 am
9:45 – 10:00 am
Welcome and Introductions (Organizer & OHRP)
10:00 – 11:00 am
A Philosopher's Look at the Belmont Principles
This session will discuss the Belmont Report Principles and offer insights on how to apply them to research studies where the regulations do not apply or are silent.
11:00 am – 12:00 pm
Participant-Centered Informed Consent
This will be an interactive session to explore what a participant-centered informed consent may look like under the instructions of the Common Rule.
12:00 – 1:00 pm
1:00 – 2:15 pm
Case Discussion - Reviewing research under the Common Rule
During this interactive session, OHRP will invite the audience to review and make decisions on the ethics and aspects pertaining to the human research protections regulations regarding a variety of research projects.
2:15 – 2:30 pm
Supporting community engagement – OHRP resources
With the expansion of community engagement, many more entities and people may become involved in the conduct of research. This session will provide an overview of OHRP resources that could be used to train and engage the community in protecting participants of research.
2:30 – 2:45 pm
2:45 – 3:45 pm
Case Studies Presented by HRPP Staff and IRB Chairs
The session will allow HRPP staff and IRB Chairs to present several case studies for audience discussion and analysis.
Speakers: ORAU and other conference organizers
3:45 – 4:30 pm
But what does the Common Rule mean by “Readily Ascertained” Anyway?
This session will review when the identity of the subject is or may readily be ascertained by the investigator or associated with the information or biospecimen. Audience will be invited to conduct mock reviews of studies and discuss what we commonly understand to be “readily ascertainable.”
*Food and beverages provided courtesy of local organizers/external sponsors. OHRP funding does not support this portion of the event.
March 30, 2023
7:30 – 8:30 am
8:30 – 8:45 am
Welcome and opening remarks – RCF Co-Host (Cathy Fore, Senior Director of University Partnerships at ORAU) and the Office for Human Research Protections (OHRP)
8:45 – 9:45 am
Keynote Address: Renee Cummings, MA, MS, Professor of Practice in Data Science, UVA School of Data Science
Ms. Cummings will address the topic of using AI and other novel technologies for research into existing and innovative crime prevention strategies and explore the special considerations for conducting this type of research with human participants and with private identifiable data.
9:45 – 10:45 am
Plenary Session 1: Karriem Watson, MPH, DHS, Chief Engagement Officer at NIH All of Us Research Program
Dr. Watson will describe where the NIH “All of Us” research program is now and address how the research aims to overcome challenges it has faced since its launch. Dr. Watson will also describe how “All of Us” leveraged the use of technology for recruitment, retention, and data collection and explore whether technology has hindered or helped the “All of Us” effort.
10:45 – 11:00 am
11:00 am – 12:00 pm
Plenary Session 2: Big Data Research
Ivor Pritchard, Ph.D., Senior Advisor to the Director at the Office of Human Research Protections (OHRP)
Dr. Pritchard’s presentation will examine how the history of technology has transformed the meaning of “privacy.” His examination will include U.S. Constitutional, legal, and regulatory interpretations of the term and the right to privacy, to raise the question of how information could be considered public, private, or something else.
12:00 – 1:00 pm
1:00 – 2:00 pm
Artificial Intelligence and Machine Learning
This session will explore how we can work to reduce the risk that data used in AI/ML research will further perpetuate societal biases and cause harm to disadvantaged or marginalized populations; ethical practices and codes being developed or adopted to address the ever-growing field of AI/ML research; emerging challenges in AL/ML research; and when AL/ML research involves “human subjects.”
Georgia Tourassi, Ph.D, Director of the National Center for Computational Sciences, Oak Ridge National Laboratory
Jacob Metcalf, Ph.D., Data and Society Research Institute
Social Media Interventions
This breakout session will showcase research interventions using social media, explain what populations are more likely to participate in this research, and discuss experiences of these participants. Session speakers will also address challenges, ethical concerns, and issues specific to this type of research as well as discuss the ethical or practical concerns for this type of research that are not addressed by the regulatory requirements for the protection of human participants in research.
Joel G. Anderson, Ph.D., College of Nursing, University of Tennessee, Knoxville
Michael Mason, Ph.D., Children and Families at Risk at the University of Tennessee, Knoxville
2:00 – 2:10 pm
2:10 – 3:10 pm
Big Data and Biometric Research
Session speakers will address the ethical and regulatory considerations for conducting research using publicly available private information, including biometric data and other data the public or individuals might consider sensitive or confidential. Speakers will also grapple with privacy and security tradeoffs, our understanding of identifiable information, our responsibility to safeguard private identifiable information, and potential regulatory gaps. Recent research and technology examples about the use and protection of biometric data will be shared for the audience's consideration.
Hector Santos-Villalobos, Ph.D., Amazon.com
Lynne Parker, Ph.D., Min H. Kao Department of Electrical Engineering and Computer Science, University of Tennessee, Knoxville
Mobile Health Technology and Mental Health and Psychiatric Research
In this session, speakers will discuss ethical considerations when conducting research using digital health data. First, Dr. Jessica Vitak will provide a broad overview of the research space, including considerations for collecting data from mobile devices and wearables and working with diverse populations. Second, Dr. Şerife Tekin will examine recent research trends in psychiatry that uses digital technologies to conduct research on mental disorders and discuss the potential risks and ethical problems that may arise therein.
Jessica Vitak, Ph.D., Associate Professor, HCIL Director, University of Maryland
Şerife Tekin, Ph.D., Associate Professor, Director of Medical Humanities, University of Texas at San Antonio
3:10 – 3:15 pm
3:15 – 4:00 pm
A Conversation with OHRP and Wrap-up
*Food and beverages provided courtesy of local organizers/external sponsors]. OHRP funding does not support this portion of the event.
Questions: For conference-related inquiries, contact Lindsay Motz, ORAU IRB manager.