Regulatory Compliance Office (RCO)
RCO Mission
The mission of AIM-AHEAD is to close the gaps in the field of AI/ML and better engage underrepresented communities both in participation and representation. With the emergence of AI/ML becoming more prevalent in human subjects research, the regulatory landscape is evolving quickly. The RCO is comprised of members with expertise in human subjects research regulations as outlined in the federal regulations, and is well equipped to provide the infrastructure and services for AIM-AHEAD stakeholders to navigate the regulatory side of their research endeavors.
RCO Purpose
The RCO provides regulatory guidance to AIM-AHEAD stakeholders and serves as a centralized record-keeping body for AIM-AHEAD funded projects. By facilitating regulatory compliance-related guidance for all AIM-AHEAD stakeholders with regulatory questions or concerns, RCO serves as a resource for generating case-specific recommendations and solutions.
Confidentiality and Independence
Ensuring confidentiality and independence in research and compliance is not just about avoiding conflicts of interest—it is about ensuring the quality, credibility, and integrity of the work these offices undertake while maintaining high ethical standards. All members officially associated with the RCO sign a confidentiality agreement and work free and independently of any conflicts.
The RCO exists to track regulatory documentation, maintain records, and provide guidance to ensure compliance in AIM-AHEAD funded research. To achieve this goal effectively and fairly, the RCO functions with autonomy to avoid any potential influence from AIM-AHEAD leadership, investigators, or offices as regulations will drive decision-making. Decision-making in this office follows the highest ethical standards of good research and regulatory practices. There are multiple reasons for maintaining confidentiality and independence which are outlined in our confidentiality agreement and highlighted below:
Ethical Independence
- Avoiding Undue Influence: Maintaining independence ensures that decisions or findings aren't influenced by external pressures, be it from funders, stakeholders, or other parties with vested interests.
- Maintaining Objectivity: Independence from other entities or interests ensures that research or compliance assessments are objective and free from bias.
- Ensuring Unbiased Decision-Making: Independence is essential for unbiased decision-making that prioritizes the welfare of participants, stakeholders, and the broader community over financial or political considerations.
- Integrity of Data and Processes: The credibility of research outcomes or compliance findings is based on their integrity. Any perceived or actual bias can undermine the trust stakeholders have in these processes.
- Legal and Contractual Obligations: Research institutions may enter into contracts or agreements that require certain information to be kept confidential. Breaching these can lead to legal repercussions.
- Protect Sensitive Information: Research often involves sensitive data, whether about individuals, proprietary technology, or business operations. Revealing such information can lead to breaches of privacy, intellectual property theft, or other harmful consequences.
- Reputation and Trust: Stakeholders, including the public, are more likely to trust and respect the findings of research and compliance offices that are known to operate with confidentiality and independence.
- Avoid Financial Conflicts: Especially in compliance, financial entanglements with other parts of an organization or external entities can create situations where there is an incentive to overlook or downplay issues.
Confidentiality in Research
- Protection of Participants: Research, especially in the medical and social sciences, often involves human participants. Confidentiality ensures that the personal information, health data, or other sensitive details of these participants remain private, safeguarding their rights and well-being.
- Maintain Research Integrity: Keeping certain details confidential helps prevent data manipulation, bias, or external influence, ensuring that the research is genuine and not influenced by external parties.
- Intellectual Property Protection: Research often results in new inventions, discoveries, or methods. Confidentiality safeguards intellectual property, ensuring that researchers and institutions receive appropriate credit and potential financial benefits.
- Avoiding Conflict of Interest: Confidentiality helps in preventing conflicts of interest, especially when research might have financial implications or when researchers have relationships with private companies.
- Promote Open Sharing: If participants and collaborators are assured of confidentiality, they are more likely to share honest, comprehensive data, leading to more accurate and valuable research outcomes.
- Data Protection Regulations: Many countries have strict data protection laws that mandate the protection of personal information. Regulatory and compliance offices must ensure that research complies with these laws.
- Protecting Institutional & Programmatic Reputation: Maintaining confidentiality ensures that the institution and the program upholds its reputation for conducting ethical and high-quality research.
- Ensuring Future Collaborations: If an institution is known to maintain confidentiality rigorously, it is more likely to be trusted and chosen for future collaborative research projects.
Meet the RCO
Director
Dr. Rajbir Singh is The Executive Director for Precision Medicine and Health Equity Trials Design at Meharry Medical College. He also serves as the Director of Clinical and Translation Research Center of Excellence (CTRCOE) and Co-Director for Center for Women’s Health Research (CWHR). He is the current Chair of IRB at Meharry Medical College. He serves as the Principal Investigator (PI) of multiple genomics trials: Implementing Genomics in Practice (IGNITE) Consortium trials, Genomic Testing to Understand and Address Renal Disease Disparities In US (GAURDD-US), testing participants for APOL1 gene, and A Depression and Opioid Pragmatic Trials in PGX (ADOPT PGX), testing for CYP2C19 and CYP2D6 genes for targeted therapy recommendations.
He is the Meharry site PI of the Phase-III of PCORI for STAR CRN. He is also associated with the Electronic Medical Records and Genomics (EMERGE) trial to have genomics implemented via EMR. Working closely with the community engagement core at Meharry, Dr. Singh has led and coordinated more than 50 clinical trials, including oncology clinical trials, pharmaceutical trials, and the recent Novavax clinical trial for the COVID-19 vaccine. As the lead on these trials, he oversaw the ongoing trial activities across the project life cycle. His participant-centered strategies have led to the highest rate of enrolment of minority communities in clinical research at Meharry. His core mission is to increase the participation of under-represented or underserved communities impacted by health disparities in clinical research for building health equity.
Co-Director
Dr. Basha (PhD, FADLM) is a tenured Professor and Vice Chair for Research in the Department of Pediatrics and Women’s Health, at the University of North Texas Health Science Center, Fort Worth, TX.
He is also serving as the Director of Research in the Institute for Health Disparities. His research
is focused on improving cancer therapies in various cancers. Dr. Basha has been working closely with physicians and researchers and emphasizes the translational principle of “bench to bedside”. Recipient several research presentation awards from the Society of Toxicology and the best presentation award at the International Conference on Drug Discovery and Therapy held in Dubai. Co-authored more than 100 publications, served as Guest Editor for two journals and edited three books. He is a member of several scientific societies including, Association of Biotechnology and Pharmacy (ABAP), American Association of Cancer Research, American Association of Clinical Oncology and Association for Diagnostic and Laboratory Medicine (ADLM) Academy and became Fellow of ABAP and ADLM.
Co-Director
Sara Stienecker (MS, MBA) is a skilled project manager and researcher who leverages business acumen and scientific background to provide structure and support to cutting-edge research projects. Sara is a highly experienced technical writer with budgeting skills and team management skills honed through years of collaborative research and programmatic efforts. Sara received her M.S. Degree in Biology from Bowling Green State University and her Master of Business Administration (MBA) from The Ohio State University. Sara's academic special interests are in Artificial Intelligence, Machine Learning, healthcare, environmental, sustainability, and governance (ESG) business strategy, programmatic development, and health equity.
Co-Director
Jessica Lyons (MA Harvard) is the Associate Director for Research and Development in the Department of Biomedical Informatics at Harvard Medical School. Jessica has spent her career working in program and data management in academic and clinical research settings and has worked on many large consortium projects involving big data and infrastructure development to support data science, AI and ML. Jessica received her MS degree in Medical Informatics from Northwestern University. Jessica’s interests are in regulatory compliance, enabling research through FAIR (Findable, Accessible, Interoperable and Reusable) access to data and infrastructure tools, and data security.
Co-Director
Erin “Tucker” Tucker leads Research Compliance at OCHIN, Inc. Tucker has a long career dedicated to research compliance. She is an asset in ensuring that ethical research practices are upheld in the pursuit of scientific advancement. Specializing in distilling intricate regulatory requirements into easily understandable components and facilitating knowledge gaps in human research requirements, she strives to empower researchers and institutions with the knowledge and tools they need to navigate the human subject research regulation landscape. Tucker has a deep commitment to advancing health equity while safeguarding the rights and welfare of research participants.
Regulatory Compliance Manager
John began his research career with the University of Pittsburgh (Pitt), where he earned his BS in Neuroscience in 2012. During his time at Pitt and after graduation, John held various roles within the research fields of endocrinology, infectious disease, neuroscience, pulmonary and critical care, and the microbiome. John then earned his MPH, focusing on Maternal and Child Health, from the University of Pittsburgh Graduate School of Public Health in 2019 and began working for the Institutional Review Board (IRB) for Pitt in December of 2020. While with the IRB at Pitt, John worked as an IRB Specialist, contributing as an independent reviewer and championing assorted educational initiatives for University faculty, staff, students, and other members of the research community. Now the Regulatory Compliance Manager for AIM-AHEAD, John brings a diverse skillset of scientific knowledge and regulatory understanding to ensure the sound success of the consortium’s initiatives.