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In the rapidly expanding field of cellular and gene therapy (CGT) research, it’s important to be aware of legal considerations related to recruiting human subjects.

Cellular apheresis refers to the procurement of cells to be used for cell therapy or clinical trial research. Protecting the rights of study participants during the collections process is a critical component of cell therapy research.


Cell Therapy Research Funding & Regulation

The National Institutes of Health (NIH) is the largest supporter of biomedical research and development in the world, funding approximately 30 percent of all health research in the United States. In addition to being the largest funder, NIH also generates the protocols for reviewing the ethics of medical and scientific research—including whether a plan for selecting research participants meets applicable legal requirements. The primary requirement is that an Institutional Review Board (IRB) reviews and approves proposed research plans before the work is begun, and again at least once per year while the human subjects research is ongoing.

The Office for Protection from Research Risks (OPRR), overseen by the U.S. Department of Health and Human Services (DHHS), is responsible for regulating the protection of human research subjects rights and welfare. The U.S. Food and Drug Administration (FDA)’s IRB review requirements match those of OPPR and apply to studies involving experimental drugs (which includes cellular and gene therapies), devices and biologics. The FDA regulates cellular and gene therapies under numerous legal guidelines including general drug, biologic, medical device, human cells, tissues and cellular and tissue based products (HCT/Ps) laws and regulations.

Institutional Review Board

An IRB is an independent committee composed of at least 5 members who each have expertise in different relevant academic backgrounds. The responsibility of the IRB is to review and evaluate research plans and materials to ensure the welfare and rights of human subjects are protected.

The IRB reviews proposed research protocols (how the information or, in the case of CGT, the blood samples will be collected by cellular apheresis), and they review any study materials such as informed consent documents and brochures describing the study’s purpose and the background of the principal investigators.

The purpose of the IRB review is to assess the ethical compliance of the study procedures, ensure potential research subjects are fully informed, choose to participate on a voluntary basis and are capable of making that decision independently and maximize the safety of study participants.

How CCS Can Support Your Cellular & Gene Therapy Clinical Trial Subject Recruitment

For many years, Comprehensive Cell Solutions (CCS) has recruited participants for studies that involve collection of mononuclear cells, hematopoietic stem cells and other components by apheresis. CCS has access to hundreds of thousands of normal, healthy donors and uses IRB-approved protocol and FDA-approved equipment. CCS human subject recruiters are highly trained key personnel, familiar with complex research protocols and human subject education and recruitment, ensuring donors are informed and recruited safely.

An industry leader, New York Blood Center’s Comprehensive Cell Solutions draws on its broad expertise and extensive infrastructure to ensure clinical trials are successfully implemented and meet or exceed FDA certification requirements. CCS PhDs and MDs are leaders in transfusion medicine, cellular therapy, immunology and epidemiology, and have designed, reviewed and overseen hundreds of research projects, preclinical and clinical studies. CCS infrastructure includes blood operations, translational center, medical programs and services, and a growing network of collaborating blood and research centers across the country.

For more on how CCS has made a name for itself in the cell therapy space since 1992, download and read the May 2019 edition of AABB News here.