Research Compliance Professional's Handbook

  1. Copyright for Research Compliance Professional's Handbook, 3rd Edition

    Research Compliance Professional's Handbook, Third Edition  | March 2019 

    Research Compliance Professional’s Handbook, Third Edition is published and updated by the Health Care Compliance Association, Minneapolis, MN...

  2. Contributors for Research Compliance Professional's Handbook, 3rd Edition

    Research Compliance Professional's Handbook, Third Edition  | March 2019 

    HCCA would like to thank all who helped produce this book...

  3. 1 Research Compliance 101

    Research Compliance Professional's Handbook, Third Edition  | Authors: Lisa Murtha, Debbie Troklus, Nicole Visyak, Draco Forte  | March 2019 

    Clinical research compliance has become a major focus area of compliance professionals in recent years. Clinical research is highly regulated and as such, the role of a compliance professional is vital to maintaining compliance with NIH, FDA, ORI CMS and OMB requirements. The laws and regulations related to human subject protections, grant and trial accounting, effort reporting, scientific misconduct, privacy and security and clinical trial billing are highly complex and always evolving. This chapter will outline some of the key compliance issues important in research today...

  4. 2 Options for Identifying and Managing Financial Conflicts of Interest in Research: Flexible Compliance with the PHS Final Rule

    Research Compliance Professional's Handbook, Third Edition  | Author: Stuart Horowitz  | March 2019 

    Merriam-Webster Online defines conflict of interest (“COI”) as: “a conflict between the private interests and the official responsibilities of a person in a position of trust.”...

  5. 3 Scientific and Research Misconduct

    Research Compliance Professional's Handbook, Third Edition  | Author: Juliann Tenney  | March 2019 

    Scientific and research misconduct may present the most vexing of challenges for the compliance officer. Lines of inquiry that have been supported by human and animal subjects (and sacrifice), as well as significant financial investment, can be wholly discredited and rendered worthless if misconduct has occurred. Careers may be ruined and institutions shamed. Settlements, fines and awards deplete resources and imprisonment may await those who would perpetrate fraud upon the government. Investigators may be excluded from participating in Public Health Service (including National Institutes of Health) and National Science Foundation supported research. In addition, private causes of action from defamation...

  6. 4 Biosecurity, Biosafety, and Biorisk Management

    Research Compliance Professional's Handbook, Third Edition  | Author: Daniel Kavanagh  | March 2019 

    Historically, the terms biosafety and biosecurity have had closely related and sometimes overlapping definitions. Today, a useful way to think about the two terms is that the goal of biosafety is to manage the risk of accidental release or unintended effects of potentially hazardous biological materials; whereas the goal of biosecurity is to manage the risk of intentional or malicious misuse of hazardous biological materials. Biosafety and biosecurity are important considerations in a broad range of endeavors from plant and animal agriculture to environmental protection; however this chapter is specifically focused on implications for human clinical research and human health...

  7. 5 The Regulation of Research Using Animals

    Research Compliance Professional's Handbook, Third Edition  | Author: Kristin H. West  | March 2019 

    The area of animal research presents a myriad of regulatory and ethical issues. Currently, clinical trials in animals are required as a condition to approval of new drugs by the U.S. Food and Drug Administration (FDA),[2] and thus, animal research plays an important role in pharmaceutical innovation. Accordingly, research compliance officers should be familiar with the regulatory requirements governing animal research. This chapter will provide an overview of the regulatory structure that governs animal research and includes a discussion of the following topics:...

  8. 6 The Regulation of Research with Human Subjects

    Research Compliance Professional's Handbook, Third Edition  | Author: Scott J Lipkin  | March 2019 

    Research involving human subjects is governed by various federal regulations, state laws, institutional based policies, and whenever applicable, accreditation standards. This chapter will provide an overview of the regulatory framework that governs human research and will:...

  9. 7 FDA-Regulated Clinical Research

    Research Compliance Professional's Handbook, Third Edition  | Author: Darshan Kulkarni  | March 2019 

    The U.S. Food and Drug Administration (“FDA”) oversees clinical trials involving drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing regulations. This chapter describes the types of trials regulated by the FDA, the major regulations governing conduct of those trials, responsibilities of sponsors and investigators in performing FDA-regulated trials, what to expect from an FDA inspection of a clinical trial and how to respond...

  10. 8 Research Privacy and Security: Myths, Facts, and Practical Approaches

    Research Compliance Professional's Handbook, Third Edition  | Authors: Marti Arvin, Kathleen Price, David Vulcano  | March 2019 

    An individual’s right to privacy has been a well‑established principle in the American healthcare system for a long time. A healthcare provider or researcher has an obligation to protect the confidentiality of a patient’s or subject’s identifiable private information against unauthorized use or disclosure. These principles have deep historical roots. Indeed, a physician’s duty to treat as confidential any information gained when caring for a patient dates back to around the time of the Greek philosophers,[2] and is well-ensconced in Anglo-American law and jurisprudence.[3] It is also one of the general principles articulated in the Declaration of Helsinki: “It is...

  11. 9 Research Records Management

    Research Compliance Professional's Handbook, Third Edition  | Authors: Carole A. Klove, Heather Kopeck  | March 2019 

    Records management presents an ongoing challenge for all healthcare entities; however, it is especially complex and challenging for clinical research due to the existence of two separate sets of records—the legal medical record and the research record. Each record set has a set of regulatory requirements that govern the management of documents included in the record. Navigating those myriad requirements requires a systematic approach...

  12. 10 Data and Safety Monitoring

    Research Compliance Professional's Handbook, Third Edition  | Authors: Susan Partridge, Steven Brown  | March 2019 

    Data and safety monitoring of a clinical trial consists of oversight of an ongoing study. This oversight ensures that study participants are protected from unforeseen and potentially avoidable risks, and that the trial produces valid data. The premise for data and safety monitoring is that despite one’s best efforts in designing a trial, one can never fully anticipate what happens as a study progresses. During the course of a trial, study populations may respond differently than expected, accrual of subjects may be skewed for unforeseen reasons, unexpected operational or compliance problems could impact outcomes, unanticipated adverse events or new drug...

  13. 11 Clinical Research Billing Compliance

    Research Compliance Professional's Handbook, Third Edition  | Author: Ryan Meade  | March 2019 

    The goal of this chapter is to discuss clinical research billing compliance. The regulations and reimbursement rules associated with billing third-party payors are not static and providers should consult federal, state and individual commercial insurance contracts to ensure the most up to date rules are applied to their claims for services. The regulations and rules are also heavily subject to interpretation due to lack of published commentary by federal and state governments...

  14. 12 Grant Management

    Research Compliance Professional's Handbook, Third Edition  | Authors: Tammie Bain, Jennifer Laporte  | March 2019 

    What does it mean to be compliant in grants management? It means an institution is fulfilling its sponsor-required obligations as part of accepting a sponsor’s funds to conduct research or perform an activity. Institution-wide solutions to ensure grant management compliance may include all areas from grant personnel to institutional support functions (such as payroll services) to upper leadership (such as conflict of interest committees). A successful compliance program requires careful documentation and cohesiveness of policies, practices, procedures, and controls, as well as a strong sense of who is responsible for various activities and role delineation...

  15. 13 Research Auditing and Monitoring

    Research Compliance Professional's Handbook, Third Edition  | Author: Sheryl Vacca  | March 2019 

    Effective compliance programs include auditing and monitoring as key elements to their success. The Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) has emphasized in several publications that an ongoing evaluation process is critical to a successful compliance program. The Federal Sentencing Guidelines (FSG) require that an organization takes reasonable steps to ensure it follows its compliance and ethics program, including auditing and monitoring to detect criminal conduct. In designing auditing and monitoring activities, it is important that the research compliance professional work closely with the organization’s chief compliance professional in order to gain...

  16. 14 What are Export Controls?

    Research Compliance Professional's Handbook, Third Edition  | Author: Kelé Piper  | March 2019 

    International research activities often involve the exchange of information or technology. It is vital to understand that export controls do not always apply to a physical shipment of a “thing,” but can also be the exposure of technological knowledge to foreign persons, entities, or countries, both on foreign or domestic soil. This is called a “deemed export.” While this may seem a little overwhelming, certain exclusions apply to research activity...

  17. 15 Integrating Research Compliance into the Corporate Compliance Program

    Research Compliance Professional's Handbook, Third Edition  | Author: Wendy Schroeder  | March 2019 

    Defining a research compliance infrastructure and implementing standard operating procedures (SOPs) poses challenges for many institutions and hospitals. Fostering research compliance within the complexity of an Academic Medical Center (AMC), hospital or university system often ends up in silos of effort within the different facilities or institutions and can even result in conflicting SOPs between departments. Small hospital systems struggle with multiplex compliance issues so that research compliance is neither a priority nor an area of domain knowledge for most compliance officers...