IRB Advisor – October 1, 2009
October 1, 2009
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New York's stem cell board approves payments to egg donors for research
The board that oversees New York state's $600 million stem cell research program will allow researchers to pay compensation to women who donate eggs for research a decision believed to be the first in the U.S. to allow state research money for this purpose. -
Egg donor payments raise issues for IRBs
It could be months before IRBs in New York state may see any protocols calling for compensation of women who donate eggs for stem cell research. -
Creating a thoughtful policy for proxy consent
The use of proxy consent for adults who lack the capacity to consent on their own is a complicated issue, thanks to vague and often inadequate state laws describing who can make such decisions. -
"Whistleblower" hotlines show participant concerns
When a human subjects protection program wants to ensure that participants have a confidential means of reporting concerns about studies, one alternative is a commercial "whistleblower" hotline service, which provides anonymity to callers. -
Ethics consultation services answer faculty questions
Research enterprises rarely offer staff ethics consultation services, although a clinical ethics consultation service commonly is offered in hospitals to physicians. -
Compliance Corner: Streamlined on-line UP/SAE reporting cuts workload
A new online decision tree for reporting unanticipated problems (UPs) and serious adverse events (SAEs) has helped a research ethics office reduce unnecessary paperwork and reports and improved compliance with the institution's policies and federal regulations, an IRB compliance coordinator says. -
Ask2-4U: Speaking with sponsors directly can quickly resolve some issues
Device sponsors and others often seek answers and input from Marti Benedict, RN, BSN, chief compliance officer for research at SUNY Upstate Medical University in Syracuse, NY. -
IRB Clinical Research News: Two new rules clarify patients access to INDs
The U.S. Food and Drug Administration (FDA) published two final rules on Aug. 13, 2009, detailing how seriously ill patients might gain access to investigational new drugs.