Biomedical Research: Human, Animal and Bench Science

Our experience in research includes:

• Clinical Trials
• Clinical Trials Implementation and Operations
• Research Misconduct, and Communicating with Professional Journals regarding Retractions
• Foreign Influence in U.S. Research
• Governmental Investigations and “Whistleblower” Complaints
• Biosafety
• Compliance Reviews/Client Investigations
• Anti-Corruption Laws
• Conflicts of Interest and Commitment
• Secondary Use of Data and Specimens
• Economic Sanctions and Export Controls
• Billing Research-Related Clinical Services
• Research Compliance Program Design and Implementation
• Government Grants and Contracts, Including in International Contexts
• IRB, IACUC and the Responsible Conduct of Research Education
• Institutional Research Policies
• Business Issues Related to Research

Clinical Trials.  We have represented a variety of research sponsor and research site clients concerning all regulatory aspects of clinical trials compliance, including in defense of FDA, OHRP and other national research authority investigations, and have assisted clients in the prophylactic planning of clinical trials, including those involving emerging economies, in order to minimize legal risk. We have, for example, investigated and helped to rectify situations of significant noncompliance in clinical trials with ICH and national research laws, including failure to report adverse events or SUSARs, failure to gain informed consent, and falsification or fabrication of CRFs.

Clinical Trials Implementation and Operations. We routinely assist research sponsors and research institutions on the development of template agreements or the negotiation of specific agreements integral to the implementation of a clinical trial, including clinical trial agreements and contract research organization agreements. We advise clients on regulatory questions that arise in the context of a clinical trial (e.g. subject recruitment, financial disclosure, charging for investigational product). 

Research Misconduct, and Communicating with Professional Journals Regarding Retractions.  We assist clients in responding to allegations of research misconduct, which generally involve the falsification or fabrication of research data, and plagiarism. We are familiar with the extensive array of issues facing clients whose employed scientists, post-doctoral fellows, investigators, faculty or medical staff have been accused of scientific misconduct, including in matters relating to the preservation of evidence, the conduct of inquiries and investigations, reporting obligations, the relative responsibilities of participants in regard to jointly awarded grants, duties to notify the FDA, NIH or other governmental agencies, and liability relating to defamation. We have substantial experience in interacting with journals and professional societies that have received presentations or have published articles affected by research misconduct.

Foreign Influence in U.S. Research. We have assisted clients with their responses to inquiries from the National Institutes of Health (“NIH”), the Department of Justice and the Department of Defense. We also provide strategic advice on government investigations, NIH’s evolving grant standards, and the NIH and U.S. Government efforts to address undue “foreign influence” in U.S.-funded research.  We have advised also many institutional clients on investigations of researchers’ participation in foreign a  scientific talent recruitment programs and in industrial espionage efforts.

Governmental Investigations and “Whistleblower” Complaints. We advise research sponsors and research institutions in their responses to “whistleblowers” and other allegations of misconduct, and in investigations by federal agencies including: the National Institutes of Health (NIH), the Food and Drug Administration, the HHS Office for Human Research Protections (the successor to the Office for Protection from Research Risks), the Office of Research Integrity, the Office of Laboratory Animal Welfare, and other agencies. We have handled many cases initiated by “whistleblowers” and, working with our colleagues in Ropes & Gray’s white collar defense practice, have experience counseling clients involved in joint whistleblower/governmental cases. We assist clients in analyzing past compliance practices, responding to governmental inquiries, implementing corrective action plans, and negotiating corporate integrity agreements or other settlement agreements to resolve such inquiries. We often identify other consultants (for example, in forensic or grants accounting) and coordinate their work as part of our work product.

Biosafety.  We routinely advise academic medical centers, universities, and industry regarding the requirements for research to be conducted under the oversight of an institutional biosafety committee (“IBC”).  We counsel clients on compliance with the National Institutes of Health policy on recombinant DNA research and attendant state and local policies governing this type of research.  We additionally have experience in advising clients regarding the biosafety requirements of the Centers for Disease Control and Prevention and the United States Department of Agriculture regulations and guidance on the use of select agents, including in the context of non-human primate research.

Compliance Reviews/Client Investigations. We design and conduct routine and focused compliance reviews of research policies and procedures, identifying strengths and weaknesses for our client’s consideration, and revising policies as necessary. We also conduct targeted internal investigations when the client believes its internal procedures, external regulations, or agreements may have been violated, or an issue has been raised by a complaint or allegation. We help research enterprises, institutional review boards, and investigators determine whether, and in what manner, their practices may not comply with federal regulations and if research activities should be altered or temporarily suspended to achieve an acceptable level of compliance.

Anti-Corruption Laws.   We advise life sciences companies, healthcare institutions, research institutions, and universities in relation to potential violations of anti-corruption laws, including the Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act in connection with clinical trials, basic research programs, and use of research grant funding.  Using our experience and knowledge of the FCPA, U.K. Bribery Act and other anti-corruption related laws, we handle criminal, civil and administrative investigations and enforcement actions conducted by federal and state law enforcement, internal investigations of potential violations of laws, and design and implementation of global compliance programs targeted at mitigating corruption risk in connection with clinical and other research programs.  We also provide counseling and due diligence with regard to corruption risks involved in multinational transactions involving institutions that conduct biomedical and scientific research.

“Big Data” Research and Secondary Use of Data and Specimens. The issues in "big data" research- including genomics and genetics research - loom large for many clients. Many “big data” analytics activities implicate a wide variety of legal and regulatory regimes, including the Food and Drug Administration (“FDA”) regulations on human subjects research, state privacy laws governing use and disclosure of sensitive health information, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), state consumer privacy and online privacy laws including the California Consumer Privacy Act and California Online Privacy Protection Act, the Telephone Consumer Protection Act (“TCPA”), and the European Union’s General Data Protection Regulation (“GDPR”).We have been advising clients in diverse industries - pharma, information technology, health providers, universities, and venture capital on automated refinement of electronic algorithms using human-derived data to develop products and services, and the legal restrictions on these uses.

We advise clients also on secondary uses of data and biological specimens, particularly for research purposes.  A wide array of health care and life sciences clients seek to reuse data and biological specimens collected for one purposes (e.g., clinical care) for a secondary purpose (e.g., research, product development, real world evidence, and marketing).  This data often includes genetic and genomic information, which implicates both federal and state health care regulations, research regulations and privacy laws and regulations. 

Economic Sanctions and Export Controls.  We advise clinical trial sponsors, sites, and service providers (including life sciences companies, academic medical centers, and research institutes) in complying with all aspects of U.S. economic sanctions and export control laws, which are evolving—and growing in scope and reach—at an ever-expanding pace.  We routinely represent clients in government and internal investigations of suspected noncompliance with U.S. sanctions and export control laws, and we have assisted clients to disclose and successfully resolve potential violations of U.S. trade laws committed by researchers.  We also assist clients to develop and enhance their economic sanctions and export control compliance programs, including with respect to restricted party screening, export classification and licensing, contracting, and investment strategies.

Billing Research-Related Clinical Services. We advise investigators and clinical sites concerning the integration of research and clinical activities, including the proper billing procedures for medical services rendered to patients involved in clinical trials. We help create policies and practices that coordinate the activities of various departments, ensuring the adequacy of clinical trial budgets and preventing insurance billing that is inconsistent with research protocols or federal reimbursement rules. Billing practices in this area have been the focus of recent increased scrutiny by the federal government.

Research Compliance Program Design and Implementation. We help participants in the research field to design and implement compliance programs for all aspects of their operations:  human research, animal research, external grant and contract funding, export controls, conflicts of interest and commitment, and research misconduct. These programs are often developed and implemented – or materially revised and improved – in connection with government or other funder audits, qui tam suits, corporate integrity agreements, or other agreements reached with various federal authorities. 

Government Grants and Contracts, Including in International Contexts. Much of the research industry is powered by grant and contract funds that flow from agencies of the federal government, including NIH, CDC, HRSA, Department of Energy, Department of Defense/DARPA, Department of Education, and NSF.  With these funds come complicated terms and conditions governing the use of funds and the scope of the work executed. We advise clients on policies and procedures to assure compliance with these terms and conditions, and defend clients when their grant and contract practices come under external scrutiny. We understand and often advise on such issues as time and effort reporting, indirect cost rates, the purchase and management of capital equipment, compliance with grant terms in international contexts, often in developing countries and emerging markets, and other matters under OMB A-21 and A-110.

Conflicts of Interest and Commitment. Our attorneys have drafted policies, procedures and forms to implement internal programs to identify and manage investigators’ and senior officials’ conflicts of interest and conflicts of commitment. These programs are designed to comply with standards issued by NIH/PHS, NSF, FDA and ICMJE, among others, and to be consistent with institutional processes relating to sponsored research applications. We have trained conflict of interest officers and committees to enable their compilations of sets of case precedents by which to assess and manage potential conflicts.

IRB, IACUC and the Responsible Conduct of Research Education. Members of the health care practice group have served as outside counsel to, or members of, IRBs and IACUCs affiliated with academic medical centers and community hospitals. We are intimately familiar with the IRB and animal research approval processes, and with the problems relating to research compliance concerns, from export controls, to attribution of authorship, to biosafety. We conduct generalized and targeted educational sessions for IRB, IACUC, and biosafety committee members and for investigators as routine compliance training, and in response to specific correction plans.

Institutional Research Policies. We develop and revise institutional research policies concerning the rights and responsibilities of grantees and investigators, all aspects of privacy in the research process, conflict of interest issues, the commercialization of intellectual property, export controls, the retention and maintenance of research data and materials, and sponsored research. Our attorneys analyze complex regulatory requirements and distill them into actionable guidelines for our clients. We have developed numerous guidance materials and operating forms to assist IRB and IACUC members, staff, and investigators in complying with regulatory requirements, such as procedures manuals, model informed consent forms, protocol review checklists, and adverse event reporting forms. We have developed guidelines for billing compliance, time and effort reporting, and other sponsored research administration rules, and have assisted clients in preparing for AAHRPP and AAALAC accreditation.

Business Issues Related to Research. We counsel a variety of clients on tax, business, and financing issues relating to research enterprises. These issues include clinical trial agreements, and the protection and licensing of technology and intellectual property, joint “incubator” projects between academic medical centers and venture capital funds, and exclusive or “first look” arrangements between research institutes and pharmaceutical companies. We also offer advice concerning ways in which a research enterprise can be financed, leveraged, or spun off.