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Institutional Safeguards
Pages 18-21

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From page 18... ... But because individual researchers cannot be expected to spot all the potential pitfalls of a project, universities, research hospitals, government labs, and many corporate labs supply a second line of defense: the institutional review board, or IRB. "Any research that is federally funded or that is being done for submission to the FDA must by law be reviewed and approved by an IRB," noted Leo Whelan of the legal department at Mayo Clinic. Read the entire page →
From page 19... ... We concluded that most IRBs were seemingly poorly informed about much that was going on at the national level or in states about the social, ethical and legal issues surrounding genetics." One potential solution, Billings suggested: "It might benefit IRBs substantially to have some sort of network of communication, and sharing of information, that apparently is not present currently. IRBs should be informed of research findings, board reprints, commissions and other sources relevant to their deliberations." Finally, David Kern argued that although the local character of IRBs may have advantages, it also carries a cost. Read the entire page →
From page 20... ... "Well over half of all the dollars spent in the United States in the pursuit of genetics-based research is spent today by private industry," mainly by pharmaceutical and biotechnology companies, said Barbara Handelin, a private genome research consultant. "Those research protocols that are not done in collaboration with an academic institution and not funded by federal moneys are not subject to IRB review." Drug companies are required to get IRB approval for any research that will be submitted to the FDA in support of a new drug, but that still leaves a great deal of private-industry research uncovered by IRBs. Read the entire page →
From page 21... ... "I think that it is incumbent upon the industry to do its own homework," Handelin said, "and I would hope that that can be done in the absence of new and burdensome regulations, that industry gets it together to take a much clearer look at the need for external review of research protocols that are being conducted by and funded by companies. I think that this industry actually should be held to a higher ethical standard than many other industries because we deal in and are given the privilege of dealing in some of the most vulnerable aspects of our society." Read the entire page →

From page 18...

... But because individual researchers cannot be expected to spot all the potential pitfalls of a project, universities, research hospitals, government labs, and many corporate labs supply a second line of defense: the institutional review board, or IRB. "Any research that is federally funded or that is being done for submission to the FDA must by law be reviewed and approved by an IRB," noted Leo Whelan of the legal department at Mayo Clinic.

Read the entire page →

From page 19...

... We concluded that most IRBs were seemingly poorly informed about much that was going on at the national level or in states about the social, ethical and legal issues surrounding genetics." One potential solution, Billings suggested: "It might benefit IRBs substantially to have some sort of network of communication, and sharing of information, that apparently is not present currently. IRBs should be informed of research findings, board reprints, commissions and other sources relevant to their deliberations." Finally, David Kern argued that although the local character of IRBs may have advantages, it also carries a cost.

Read the entire page →

From page 20...

... "Well over half of all the dollars spent in the United States in the pursuit of genetics-based research is spent today by private industry," mainly by pharmaceutical and biotechnology companies, said Barbara Handelin, a private genome research consultant. "Those research protocols that are not done in collaboration with an academic institution and not funded by federal moneys are not subject to IRB review." Drug companies are required to get IRB approval for any research that will be submitted to the FDA in support of a new drug, but that still leaves a great deal of private-industry research uncovered by IRBs.

Read the entire page →

From page 21...

... "I think that it is incumbent upon the industry to do its own homework," Handelin said, "and I would hope that that can be done in the absence of new and burdensome regulations, that industry gets it together to take a much clearer look at the need for external review of research protocols that are being conducted by and funded by companies. I think that this industry actually should be held to a higher ethical standard than many other industries because we deal in and are given the privilege of dealing in some of the most vulnerable aspects of our society."

Read the entire page →

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Institutional Safeguards Pages 18-21

Institutional Safeguards
Pages 18-21