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washington When institutional review boards fail the system
WASHINGTON
When institutional review boards fail the system
F
ederally financed research on human beings resumed last week at Duke University Medical Center (Durham, NC, USA) after a 4-day shutdown ordered by government monitors who cited numerous violations of regulations governing safety and ethical standards. The episode was brief, rare, and without evidence of harm to anyone but Duke’s pride and researchers. But it attracted a great deal of press attention at a time when ethical safeguards in medical research are under scrutiny by Congress and the National Bioethics Advisory Commission. The Duke suspension, affecting some 2000 projects, was ordered on May 10 by the Office for Protection from Research Risks (OPRR), part of the National Institutes of Health (NIH). It came after officials concluded that Duke was unresponsive to findings of deficiencies in the operation of the university’s Institutional Review Board (IRB), which is responsible for assuring conformity with federal regulations for the protection of experimental subjects. Among the violations specified were lack of a quorum at board meetings, casual waivers of experimental rules, and insufficient public representation on the IRB. Also noted was the presence on the board of a Duke official assigned to assist in bringing research grants into the university, a role potentially in conflict with keeping out impermissible research. OPRR said it acted after its warnPYONGYANG
ings went unheeded for several months. No injuries to volunteers were attributed to the board’s shortcomings, OPRR officials stated. However, after the suspension, a case was reported in which Duke failed to notify OPRR of an incident in which a volunteer lost consciousness during pressure-chamber simulation of a NASA spacewalk. Eager to remove the suspension, Duke conceded shortcomings and pledged prompt corrective measures, including intensive educational efforts to promote compliance with federal ethical regulations.
“IRBs are often forced to rush through and rubber stamp large piles of research protocols” The protection of human beings taking part in experiments has recently been drawing concerned political attention. The Duke suspension came after the March 26 shutdown of research at the West Los Angeles Veterans Hospital because of extensive deviations from ethical requirements. Last July, a House hearing on drug testing on children evoked harsh comments from several members, among them Christopher Shays (Republican, Connecticut), who declared that “the current system of bioethical review has failed miserably”. Meanwhile, the National Bioethics Advisory Commission has proposed stricter safeguards for
patients with mental disorders who are taking part in clinical trials. Under the cherished system of selfregulation by the research community, assurance of ethical compliance and safety is entrusted to IRBs. However, the IRB system is a frail safeguard, according to studies by the General Accounting Office, the watchdog agency of Congress, and the Office of Inspector General of the Department of Health and Human Services. While noting some exceptions, both reported that the duties of the IRBs often are not accompanied by appropriate resources. Without proper resources IRBs are often forced to rush through and rubber stamp large piles of research protocols, the reports stated. Close examination is rare, as are the IRBs’ rejections or requests for modifications. In some instances, researchers applying for approval of their projects were found to be sitting as members of the review board. OPRR is responsible for assuring ethical and safety compliance of 30 000 research projects financed by NIH, plus many supported by other government agencies. To carry out this role, OPRR has two full time investigators and an office-bound staff of about 30. Within NIH, which is budgeted this year for US$15·6 billion, OPRR is a very small, low-level entity. The system is largely built on trust and good faith—qualities not especially revered by Congress. Daniel S Greenberg
A starving nation
N
orth Korea has acknowledged for the first time that hundreds of thousands of its people may have died of starvation since 1995. In an unprecedented disclosure, Jon In-chen, acting director of external affairs for the government’s Food Damage Rehabilitation Committee, revealed that the mortality rate has risen by more than a third in the past 4 years. Before 1995, the mortality rate was 6·8 per 1000 people. Last year’s assessment showed that it had increased to 9·3 per 1000, Jon was quoted as telling a delegation of the United Nations World Food Program (WFP). The figure reveals that 55 000 more people than expected among North Korea’s population of 22 million people died
THE LANCET • Vol 353 • May 22, 1999
in 1998. If this increased mortality rate began in 1995, when floods, droughts, and tidal waves hit the country, the death toll over the past 4 years would be 220000. This is far lower than estimates by relief organisations, South Korean research institutes, and US congress men, who have said the famine has killed 1–3 million people. Jon said that North Korea’s birthrate has also plunged. He was quoted as say ing that the natural increase of the population fell to 0·9% last year, compared with 1·5% in 1995. Doctors at Puryong County Hospital, Komusan, one of the worst affected areas, told the WFP that half their patients were mal nourished. A situation that is likely to get worse. According to a report
by the state-run Korean Central News Agency on May 13, North Korea has had droughts since January. The worst affected areas are the east-coast cities of Chongjin, Wonsan, and Hamhung, which have had no rain for more than 3 months, the agency said. Hwanghae, the southwestern region that produces the bulk of North Korea’s agricultural output, has had less than half its usual rainfall since January. With more than 2 months until the harvest, the WFP has begun distributing food in the northeast to children and elderly. The WFP hopes to feed 8 million people this year—the most since 1995. Jonathan Watts
1773
When institutional review boards fail the system
F
ederally financed research on human beings resumed last week at Duke University Medical Center (Durham, NC, USA) after a 4-day shutdown ordered by government monitors who cited numerous violations of regulations governing safety and ethical standards. The episode was brief, rare, and without evidence of harm to anyone but Duke’s pride and researchers. But it attracted a great deal of press attention at a time when ethical safeguards in medical research are under scrutiny by Congress and the National Bioethics Advisory Commission. The Duke suspension, affecting some 2000 projects, was ordered on May 10 by the Office for Protection from Research Risks (OPRR), part of the National Institutes of Health (NIH). It came after officials concluded that Duke was unresponsive to findings of deficiencies in the operation of the university’s Institutional Review Board (IRB), which is responsible for assuring conformity with federal regulations for the protection of experimental subjects. Among the violations specified were lack of a quorum at board meetings, casual waivers of experimental rules, and insufficient public representation on the IRB. Also noted was the presence on the board of a Duke official assigned to assist in bringing research grants into the university, a role potentially in conflict with keeping out impermissible research. OPRR said it acted after its warnPYONGYANG
ings went unheeded for several months. No injuries to volunteers were attributed to the board’s shortcomings, OPRR officials stated. However, after the suspension, a case was reported in which Duke failed to notify OPRR of an incident in which a volunteer lost consciousness during pressure-chamber simulation of a NASA spacewalk. Eager to remove the suspension, Duke conceded shortcomings and pledged prompt corrective measures, including intensive educational efforts to promote compliance with federal ethical regulations.
“IRBs are often forced to rush through and rubber stamp large piles of research protocols” The protection of human beings taking part in experiments has recently been drawing concerned political attention. The Duke suspension came after the March 26 shutdown of research at the West Los Angeles Veterans Hospital because of extensive deviations from ethical requirements. Last July, a House hearing on drug testing on children evoked harsh comments from several members, among them Christopher Shays (Republican, Connecticut), who declared that “the current system of bioethical review has failed miserably”. Meanwhile, the National Bioethics Advisory Commission has proposed stricter safeguards for
patients with mental disorders who are taking part in clinical trials. Under the cherished system of selfregulation by the research community, assurance of ethical compliance and safety is entrusted to IRBs. However, the IRB system is a frail safeguard, according to studies by the General Accounting Office, the watchdog agency of Congress, and the Office of Inspector General of the Department of Health and Human Services. While noting some exceptions, both reported that the duties of the IRBs often are not accompanied by appropriate resources. Without proper resources IRBs are often forced to rush through and rubber stamp large piles of research protocols, the reports stated. Close examination is rare, as are the IRBs’ rejections or requests for modifications. In some instances, researchers applying for approval of their projects were found to be sitting as members of the review board. OPRR is responsible for assuring ethical and safety compliance of 30 000 research projects financed by NIH, plus many supported by other government agencies. To carry out this role, OPRR has two full time investigators and an office-bound staff of about 30. Within NIH, which is budgeted this year for US$15·6 billion, OPRR is a very small, low-level entity. The system is largely built on trust and good faith—qualities not especially revered by Congress. Daniel S Greenberg
A starving nation
N
orth Korea has acknowledged for the first time that hundreds of thousands of its people may have died of starvation since 1995. In an unprecedented disclosure, Jon In-chen, acting director of external affairs for the government’s Food Damage Rehabilitation Committee, revealed that the mortality rate has risen by more than a third in the past 4 years. Before 1995, the mortality rate was 6·8 per 1000 people. Last year’s assessment showed that it had increased to 9·3 per 1000, Jon was quoted as telling a delegation of the United Nations World Food Program (WFP). The figure reveals that 55 000 more people than expected among North Korea’s population of 22 million people died
THE LANCET • Vol 353 • May 22, 1999
in 1998. If this increased mortality rate began in 1995, when floods, droughts, and tidal waves hit the country, the death toll over the past 4 years would be 220000. This is far lower than estimates by relief organisations, South Korean research institutes, and US congress men, who have said the famine has killed 1–3 million people. Jon said that North Korea’s birthrate has also plunged. He was quoted as say ing that the natural increase of the population fell to 0·9% last year, compared with 1·5% in 1995. Doctors at Puryong County Hospital, Komusan, one of the worst affected areas, told the WFP that half their patients were mal nourished. A situation that is likely to get worse. According to a report
by the state-run Korean Central News Agency on May 13, North Korea has had droughts since January. The worst affected areas are the east-coast cities of Chongjin, Wonsan, and Hamhung, which have had no rain for more than 3 months, the agency said. Hwanghae, the southwestern region that produces the bulk of North Korea’s agricultural output, has had less than half its usual rainfall since January. With more than 2 months until the harvest, the WFP has begun distributing food in the northeast to children and elderly. The WFP hopes to feed 8 million people this year—the most since 1995. Jonathan Watts
1773