Human Tissue Bill could jeopardise research, scientists warn
http://www.100md.com
《英国医生杂志》
The British government is ignoring concerns of the scientific community about the potentially harmful effects of a draft law governing the retention of human tissue, the Royal Society said this week.
The Human Tissue Bill, which is currently under consideration in parliament, aims to set out ethical guidelines for medical researchers using human tissues. It was developed in response to events at Liverpool's Alder Hey Hospital and Bristol Royal Infirmary, where organs from deceased children were kept for research without parental consent.
The Medical Research Council, the Wellcome Trust, and other groups have expressed concerns that the bill in its current form will hamper essential studies, but the Royal Society said those concerns were not being listened to.
"The scientific and medical communities have been making their concerns known since the start of this bill, but the Department of Health appears to be carrying on regardless. The government must take action to ensure that these concerns are fully addressed," said Lord May of Oxford, president of the Royal Society.
Lord May said the measures in the bill were "like using a sledgehammer to crack a nut." The legislation makes no distinction between tissue samples taken during routine diagnostic tests and the removal of organs during postmortem examinations. "The prohibitive amount of bureaucracy that could be generated by the need to obtain consent for individual tissue samples would impact on teaching and lead to reduced levels of vital research into understanding diseases such as cancer, heart disease, Parkinson's, and vCJD ," Lord May said.
There are also issues relating to existing collections of stored tissues. The current bill states that these collections are exempt from the new legislation but that their use will be decided through codes of practice devised by the Human Tissue Authority, a new body that will be established under the bill. "This additional guidance could place restrictions on the use of these collections but will not be subject to parliamentary scrutiny, and researchers will have no opportunity to comment, even if it is too restrictive," said Lord May.
A spokesman for the Wellcome Trust said the charity is involved in ongoing discussions with the Department of Health about the bill. "We're hopeful that when the bill comes in its next draft, these issues will have been addressed," he told the BMJ.
The draft bill is waiting to go to the report stage in the House of Commons, during which amendments can be made. Then it moves to the House of Lords.
Health minister Rosie Winterton said the department had been talking to the medical and scientific community about their concerns.
"We are looking at ways of addressing them in the bill but maintaining the balance between the rights of individuals to be consulted and the need for vital medical research," she said.(London Stephen Pincock)
The Human Tissue Bill, which is currently under consideration in parliament, aims to set out ethical guidelines for medical researchers using human tissues. It was developed in response to events at Liverpool's Alder Hey Hospital and Bristol Royal Infirmary, where organs from deceased children were kept for research without parental consent.
The Medical Research Council, the Wellcome Trust, and other groups have expressed concerns that the bill in its current form will hamper essential studies, but the Royal Society said those concerns were not being listened to.
"The scientific and medical communities have been making their concerns known since the start of this bill, but the Department of Health appears to be carrying on regardless. The government must take action to ensure that these concerns are fully addressed," said Lord May of Oxford, president of the Royal Society.
Lord May said the measures in the bill were "like using a sledgehammer to crack a nut." The legislation makes no distinction between tissue samples taken during routine diagnostic tests and the removal of organs during postmortem examinations. "The prohibitive amount of bureaucracy that could be generated by the need to obtain consent for individual tissue samples would impact on teaching and lead to reduced levels of vital research into understanding diseases such as cancer, heart disease, Parkinson's, and vCJD ," Lord May said.
There are also issues relating to existing collections of stored tissues. The current bill states that these collections are exempt from the new legislation but that their use will be decided through codes of practice devised by the Human Tissue Authority, a new body that will be established under the bill. "This additional guidance could place restrictions on the use of these collections but will not be subject to parliamentary scrutiny, and researchers will have no opportunity to comment, even if it is too restrictive," said Lord May.
A spokesman for the Wellcome Trust said the charity is involved in ongoing discussions with the Department of Health about the bill. "We're hopeful that when the bill comes in its next draft, these issues will have been addressed," he told the BMJ.
The draft bill is waiting to go to the report stage in the House of Commons, during which amendments can be made. Then it moves to the House of Lords.
Health minister Rosie Winterton said the department had been talking to the medical and scientific community about their concerns.
"We are looking at ways of addressing them in the bill but maintaining the balance between the rights of individuals to be consulted and the need for vital medical research," she said.(London Stephen Pincock)