Thursday, November 15, 2001

Johns Hopkins University’s school of arts and sciences will soon require researchers to be trained in safeguarding their human subjects something most institutions already do.
The training program will ensure researchers understand their roles and duties such as obtaining valid informed consent and how to use guidelines and regulations to protect human subjects. It is similar to requirements implemented by the Bethesda-based National Institutes of Health in October 2000 for those seeking NIH support.
Hopkins’ training for researchers will match or exceed NIH requirements regardless of whether a researcher applies for NIH funds, Hopkins spokesman Dennis O’Shea said this week. He said administrators will also send annual reminders of the requirements.
Most major research institutions already have put such educational programs in place, said federal Office of Human Research Protections spokesman William H. Hall.
The training program was introduced after several high-profile embarrassments for Johns Hopkins.
A university committee found that an arts and science faculty member undertook human medical research in India without adequate safeguards and without review and approval from a Hopkins institutional review board.
The university has declined to identify the faculty member involved, citing a confidentiality policy, but the Associated Press has identified the professor as Ru Chih C. Huang, a biologist at Hopkins since 1965. She didn’t return calls seeking comment.
On Monday, the university barred the professor from doing research on humans unless she is supervised by a senior faculty member and the study is directed by another researcher.
The university committee did not find that any of 26 patients in her study, who received a creosote plant derivative to stop the growth of oral cancer tumors, was harmed. But the panel said the researcher did not conduct enough tests on animals before trying the experimental drug on people.
The separately run and highly regarded medical school also has been plagued with problems.
In July federal regulators stopped government-funded research on human subjects at Johns Hopkins for a few days after a healthy 24-year-old hospital employee participating in an asthma drug study died.
An Office of Human Protections report issued afterward said that Hopkins reviewers seemed to lack detailed understanding of federal regulations for protecting human subjects.
The medical school ranked for the past 11 years as one of the top two medical universities in the nation received $301 million in federal research funding last year, more than any other medical school in the country.
It uses an Internet-based program to train researchers and others responsible for reviewing and approving research proposals, spokeswoman Joann Rodgers said.
Late last week, the federal Office of Human Research Protection said the university’s medical school and affiliated institutions should be commended for changes made since the volunteer’s death, but criticized two other studies.
In one study, the regulators said a researcher failed to warn parents about serious side effects of hormones used in a study on children. In the other, researchers were criticized for giving cocaine addicts up to $700 to get them to participate.
In July, Indian news media reported physicians’ complaints that patients were not adequately protected in the creosote drug study.
In August, Maryland’s highest court criticized a study conducted by Hopkins’ Kennedy Krieger Institute on poor children exposed to lead-based paint.

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