Increasing attention is being paid by government regulators and the public to the conduct of clinical trials and epidemiological studies. On October 26, 2001, the U.S. Food and Drug Administration (FDA) announced the creation of the Office for Good Clinical Practice to oversee the conduct of clinical trials and to ensure the protection of participants in FDA-regulated research. Further, the U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP) recently suspended federally funded research at several academic medical centers and universities because of alleged deficiencies in their procedures for the protection of humans participating in research protocols. These suspensions were prompted by OHRP’s increased emphasis on regulatory compliance and enforcement, as well as by tragic adverse outcomes and information provided to OHRP by whistleblowers.
The FDA has jurisdiction over human clinical studies involving generally FDA regulated articles such as pharmaceuticals and medical devices. Detailed FDA regulations govern the conduct of clinical investigators (PIs), institutional review boards (IRBs) and sponsors of clinical studies, generally product manufacturers. The regulations (21 CFR Part 50, 56, 312, 812) are intended to protect the welfare of research subjects and to ensure the integrity of the data developed during the study so it can be relied upon by the FDA when submitted by product manufacturers. FDA enforces its regulations by conducting inspections of investigational sites and records of IRBs, sponsors and PIs. Failure to comply with FDA regulations can have serious consequences including disqualification of data from use in product approval applications, withdrawal of the authority of IRBs to approve clinical studies and of PIs to conduct studies, and criminal penalties. The FDA conducts hundreds of inspections each year, including inspections of studies conducted outside the United States.
OHRP is the regulatory body responsible for compliance with the U.S. Department of Health and Human Services (HHS) Regulations for Protection of Human Subjects (45 CFR Part 46). Institutions engaged in federally funded human subjects research are required to provide written Assurances of Compliance to OHRP that describe the means the institution will employ to comply with HHS regulations. An assurance approved by OHRP commits the institution and its personnel to compliance with these federal regulations.
In a number of well-publicized cases, OHRP suspended entire research programs covered by an Assurance. Most recently, the June 2001 death of a Johns Hopkins University (JHU) asthma study volunteer prompted an immediate, intensive review by OHRP of JHU’s research programs and IRB practices, resulting in the suspension of all JHU’s federally funded research activities. Although OHRP has lifted its suspension, its investigation continues, including a requirement that JHU submit detailed progress reports to it, and the JHU research program continues to attract negative publicity.
Other institutions have had their research programs investigated by OHRP, in some cases resulting in suspension of federally funded research and in many other cases specific corrective actions were required. Prominent recent examples include Duke University, University of Pennsylvania, University of Michigan, the University of Oklahoma Health Sciences Center-Tulsa and Yale University. Further, some institutions are now involved in lawsuits brought by study subjects and the estates of deceased subjects, challenging their approval and conduct of particular research studies. For example, the University of Oklahoma Health Sciences Center-Tulsa, including the members of its IRB and other individuals, were sued in January 2001 regarding a melanoma vaccine study, and the Fred Hutchinson Cancer Center was sued in March 2001 and again in May 2001 regarding a leukemia clinical trial and a breast cancer chemotherapy trial.
McDermott, Will & Emery Services and Experience
McDermott, Will & Emery has assisted a large number of clients in responding to government inquiries regarding research protocols and IRB procedures. The Firm is also prepared to assist academic medical centers, universities and other organizations involved in human subjects research in developing compliance plans, updating IRB operations manuals and implementing carefully designed internal audits to identify areas in need of improvement. The Firm has also assisted companies and individuals in FDA inspections, compliance and enforcement actions.
McDermott, Will & Emery’s international health law practice offers a full range of experience in human subjects research. Among our almost 100 lawyers are physicians, pharmacists, former U.S. Food and Drug Administration, U.S. Justice Department and other government officials, IRB members and others who are available to advise and assist your organization with issues relating to human subjects research, including the following:
- Government inquiries and investigations
- HIPAA and other privacy requirements
- Industry-sponsored research: tax and regulatory issues
- Internal audits of IRB operations
- International research studies
- Medicare and commercial insurance coverage
- Negotiating clinical trial agreements
- Protocol compliance and researcher education
- Quality improvement and compliance plans
- Regulatory compliance (FDA, OHRP, NCI, EPA, etc.)
Our lawyers advise a wide range of organizations regarding these issues, including the following:
- Academic medical centers
Faculty practice foundations
- Biotech companies
- Pharmaceutical companies
- Clinical investigators
- Contract research organizations
- Pesticide manufacturers