washington: the johns hopkins university in the us has admitted that one of its scientists tested experimental cancer drugs on patients in india without the required federal or university approvals and he has been barred from any future research involving human subjects. a faculty committee, appointed last summer to investigate allegations regarding the clinical trial conducted at the regional cancer centre (rcc) in kerala, found that the trial did not meet the university standards for research with human subjects and was carried out without adequate preliminary tests in animals. the report was submitted to richard e. mccarty, dean of the university's krieger school of arts and sciences, who accepted it and barred the scientist from serving as principal investigator on any future research involving human subjects, a university release here said. johns hopkins spokesman dennis o'shea declined to give the name of the scientist who has been disciplined. he told pti that the name could not be released under the confidentiality agreement to which the university is a party. he, however, noted that some reporters had given the name which the university neither confirms nor denies. asked what name the reporters have given, he said: "i can't tell you." the investigation involved a study of two experimental cancer drugs conducted by the hopkins scientist as principal investigator and indian colaborators. the trial at the rcc in kerala, involving 26 oral cancer patients, ran from november 1999 to april 2000. by july 2001, reports appeared in the media of complaints by physicians there that the trial had been improperly conducted. the johns hopkins faculty committee found that the scientist was negligent for failing to submit a proposal for the colinical trial to a johns hopkins university institutional review (irb) board. under university policy and federally mandated procedures, faculty experiments involving human subjects must have prior irb approval, whether conducted in the us or abroad. the report said that the trial did not meet johns hopkins standards for research with human subjects. for example, the committee found there was inadequate safety testing of the drugs in animals before they were injected into human patients. the committee also said that consent forms used to recruit patients for the study were inadequate. the scientist carried drugs used in the study to india without either an "investigative new drug" approval from the fda or explicit fda permission. the scientist, without authority, signed several versions of a document committing the university to collaboration with the rcc. the committee said it found no evidence that any patient had been harmed or that any patient's conventional treatment was delayed by the clinical trial. in addition to barring the scientist as principal investigator on any future research involving human subjects, the dean required that any future participation by the scientist in human studies, led by other principal investigators, must be supervised by a senior faculty member with expertise in clinical research from either the university's school of medicine or its bloomberg school of public health. the dean also imposed other oversight requirements and limitations on the scientist's work. the scientist, a faculty member in the school of arts and sciences, has the option to appeal to the vice provost for research. the university is reporting the results of its invstigation to the us food and drug administration (fda), the office of research integrity of the national institues of health and the office for human research protections of the department of health and human services.