October 1

Comments on AHRP Amicus Brief (Kennedy Krieger)

We believe the Court has clearly and unambiguously ruled on matters that have long needed judicial attention. Our Amicus brief (attached) provided the Court with a litany of additional cases demonstrating that the lead paint case, while in and of itself ethically questionable, is not unique, but is symptomatic of pervasive and widespread deficiencies in the medical research enterprise.

In our Amicus brief we have urged the Court to rule against motion for reconsideration by Kennedy Krieger Institute and their powerful supporters: Johns Hopkins University, Association of American Medical Colleges, Association of American Universities, University of Maryland, and Medical System Corp.

The Alliance for Human Research Protection (AHRP) is an association of individuals concerned about the safety and welfare of human subjects in medical research. AHRP members bring varied professional perspectives including law, medicine, psychology, psychiatry, social work and nursing to this task. Each member of the steering committee has particularized expertise in working with children or advocating for the best interests of children.

Beyond the varied professional backgrounds and experiences we bring to this task, we offer a unique point of view to this issue in that none of us have direct financial interests in the medical research enterprise. Thus, our perspective on this matter may more closely reflect the population impacted by the Court’s decision: all potential research subjects and, ultimately, the public at large.

AHRP is deeply concerned about the inadequacy of current public policies and oversight governing the conduct of medical research÷particularly research involving children.

We believe that the Court’s decision in these cases provides long-needed clarification and guidance for the ethical conduct of medical research, particularly as it affects children and others under a legal disability. In our Amicus brief we address the Court’s decision as a well-conceived statement of the rights of children serving as medical research subjects and the legal standards to which researchers are to be held.

The following individuals serve on AHRP’s steering committee:

Christopher Barden, Ph.D., J.D. is a psychologist and attorney.

Howard Fishman, M.Ed., M.S.W. is a consultant and expert witness on child welfare issues.

Loren Mosher, M.D. is a psychiatrist who is retired from the National Institute of Mental Health.

Jack Noble, Ph.D. is an endowed professor for social justice at Catholic University.

Kay Perrin, R.N., Ph.D., Public Health and child and family well-being, University South Florida.

Sally Rogow, Ph.D., professor emerita, and specialist in children with Disabilities U. of British Columbia.

Vera Sharav, M.L.S., developed a database to track ethical violations in research and organized the Alliance for Human Research Protection.

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