Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: Providing an IND/IDE Consult Service in a Decentralized Network of Academic Healthcare Centers

Under 21 Code of Federal Regulations (CFR) Part 312 and 21 CFR Part 812, sponsors of clinical investigations involving an investigational drug or device are required to submit, respectively, an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. An IND/IDE is a request for authorization by the Food and Drug Administration (FDA) for an investigational drug, biological product, or device seeking marketing approval to be administered to humans and for permission to be shipped across state lines. An IND/IDE is issued to a sponsor defined as a company, government agency, not-for-profit organization, or individual investigator (Sponsor-Investigator). Typically, an IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.1,2 Similarly, the data gathered during clinical trials of an IND become part of a New Drug Application (NDA) for review and potential approval of the product.3 Both pharmaceutical and biotechnology companies and government agencies have significant resources dedicated to regulatory processes. When a researcher becomes a Sponsor-Investigator, however, s/he may not have specific experience or training, nor institutional resources, to assume the specific responsibilities as both investigator and sponsor of the study.3,4 A Sponsor-Investigator must have the knowledge to properly follow and adhere to the applicable CFR and FDA guidelines to ensure compliance in maintaining, conducting, and reporting research under INDs/ IDEs.5,6 We sought to address this problem by developing a scalable, inter-institutional IND/IDE Consult service, described herein. About Harvard Catalyst | The Harvard Clinical Translational Science Center8 In 2008, the National Institutes of Health (NIH) awarded Harvard University a Clinical Translational Science Award (CTSA), also known as Harvard Catalyst | The Harvard Clinical Translational Science Center. The overall goal of the CTSA program is to “accelerate discoveries toward better health”7 by addressing the challenge of translation of laboratory clinical innovation into practice. Harvard Catalyst is 1 of 61 medical institutions funded through the CTSA mechanism by the National Center for Advancing Translational Sciences (NCATS) and is dedicated to improving human health by enabling collaboration and providing tools, training and technologies to clinical and translational investigators. Harvard Catalyst is a shared enterprise of Harvard University, its ten schools and its seventeen affiliated Academic Healthcare Centers (AHC)—each of which is a separate legal entity—as well as the Boston College School of Nursing, MIT, Harvard Pilgrim Health Care, and numerous community partners.1 A key component of Harvard Catalyst is the Regulatory Knowledge and Support Program (the Program) that works to minimize the regulatory burdens for investigators and to promote cooperation and interoperability by coordinating the diverse processes of inter-institutional research, including human subjects protections, patient privacy, quality improvement, and support for FDA-regulated research. In particular, the Program promotes inter-institutional cooperation and develops regulatory guidance and simplification where appropriate. In this context, the IND/IDE subcommittee of the Program regulatory oversight committee was formed to address the challenges of conducting clinical trials with IND/IDE sponsor-investigators. The membership of the IND/IDE subcommittee includes both recognized IND/IDE regulatory experts from the Harvard academic, medical, and hospital communities and those new to the regulatory compliance arena. The breadth of membership makes the Subcommittee uniquely qualified to ensure compliance of federal regulations and institutional policies and to promote best practices. The goal of the subcommittee is to assist institutions and sponsor-investigators to meet their regulatory and institutional requirements.