The U.S. Health and Human Services (HHS) Secretary Mike Leavitt has appointed UAB Research Compliance Officer Samuel J. Tilden, M.D., J.D., to chair the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The 11-member committee provides recommendations on the responsible conduct of research involving human participants, reviews activities of HHS offices and agencies responsible for human participant protection in biomedical and behavioral research and advises on policy and on program development and implementation.

Sam Tilden

Tilden, professor of pediatrics with subspecialties in pediatric critical care and pulmonology, was director of the Division of Pediatric Critical Care and medical director of the Pediatric Intensive Care Unit at Children’s Hospital for 12 years and was consultant for 10 years for the UAB Hospital Cardiac Surgery Intensive Care Unit.

“I confronted many of the same issues relating to ethics and law in both of these roles, dealing with the whole spectrum of infants, children, and adults,” he says. “That experience fostered my interest in this field. I went to law school at night and to the University of Houston one day a week for a graduate law degree, and I developed expertise in the combination of law, bioethics and regulation.”

This skill set, along with his experience as a clinical investigator and member of the UAB Institutional Review Board (IRB) for Human Use, qualified him to become the university’s second Research Compliance Officer in 2002. Two years later, as a result of a site visit by the federal Office of Human Research Protection, the UAB IRB was placed under his authority. Also as an outgrowth of that site visit, UAB applied for accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Tilden recently guided the university through a self-assessment phase and is awaiting an AAHRPP site visit scheduled for Aug. 8-10.

Tilden, who credits Senior Vice President and School of Medicine Dean Robert Rich, M.D., with recommending him for appointment to SACHRP, was a committee member for less than a year before being named to chair the panel. “Being named chairman was a vote of confidence by the agency for my early participation, but also was a fairly intimidating, big responsibility in a high profile arena,” he says.

“After chairing my first meeting, I was gratified to receive positive feedback from the agency and attendees.”

Tilden says SACHRP has completed important work in recent months. “Based on our recommendation, Secretary Leavitt asked the Institute of Medicine to evaluate research in prisoners, and its report was published this year by the National Academy of Sciences. We have just forwarded him our recommendations on research in children, and his action is pending.”

Tilden was instrumental in the formation of a SACHRP subcommittee on research in individuals with impaired decision-making capacity, primarily a population with medical disorders that result in incompetence, such as Alzheimer’s and Parkinson’s.

“As academic and industry researchers seek to find treatments for these disorders, we face tough bioethical and legal issues that have never been adequately addressed,” he says. “There are no regulations specific to this area.”