Human clinical trials, animal research, basic research programs, and the use of research funding are areas subject to heightened public scrutiny and government enforcement. Ropes & Gray represents many participants in biomedical and basic science research, including pharmaceutical and medical device companies, biotechnology firms, academic medical centers, pediatric and other specialty hospitals, universities, research institutes, and clinical research organizations. Our research compliance specialists, some of whom have held senior research and legal positions in prominent universities and medical centers, represent these entities in their efforts to achieve and maintain regulatory compliance. We also assist these organizations in defending their research programs. We have extensive experience relating to the management of international research and development projects, including in assuring adherence to the Foreign Corrupt Practices Act and securing national research authority approvals for clinical trials, particularly in developing countries or emerging economies.
- All regulatory aspects of clinical trials compliance
- Responses to “whistleblowers” complaints and other allegations or investigations by federal agencies
- The design and performance of routine and focused compliance reviews of research policies and procedures as well as targeted internal investigations
- Responses to allegations of research misconduct, and communications with professional journals regarding retractions.
- The integration of research and clinical care
- Research compliance program design and implementation
- Compliance with government grants and contracts, including in international contexts
- Conflicts of interest and commitment
- IRB, IACUC and the responsible conduct of research education
- Institutional research policies
- Business issues related to research
Our experience in research includes:
- Clinical Trials
- Clinical Trials Implementation and Operations
- Governmental Investigations and “Whistleblower” Complaints
- Compliance Reviews/Client Investigations
- Research Misconduct, and Communicating with Professional Journals regarding Retractions
- Integration of Research and Clinical Care
- Research Compliance Program Design and Implementation
- Government Grants and Contracts, Including in International Contexts
- Conflicts of Interest and Commitment
- 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).
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.
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.
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.
Integration of Research and Clinical Care. 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 establishing 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 them to compile a set of case precedents by which to assess potential conflicts and assure their appropriate management.
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.