Posts Tagged ‘nih guidelines’

Industry Funded? Do Tell!

 :: Posted by American Biotechnologist on 08-03-2010

Drug Discovery News recently reported a proposed change to the National Institute of Health’s (NIH) policy on financial conflict of interest (FCOI) disclosure. Under the proposed regulation, academic institutions will assume responsibility for reporting to the NIH any FCOI above $5,000. Currently, individual scientists, (as opposed to institutions), are responsible for reporting FCOIs in excess of $10,000.

It is hoped that moving the disclosure obligation from the individual scientist to the institution will be accompanied by the implementation of a systematic review process and technological infrastructure only available at the institutional level.

Although the proposed changes will make the system more robust and transparent, it will also make it more difficult for multi-disciplinary teams comprised of both academic and industrial scientists to secure NIH Phase I funding. This may slow down the pace of “translational” research since most “bench-to-bedside” studies are comprised of teams from both academia and industry.

Over the last number of years we have seen a significant push towards funding “translational” academic research which may be more palpable to the general public than pure academic science. Government funding of granting agencies is partially based on the electorate’s perception of what’s important in the current environment. Since it is easier to convince Joe Public of the importance of translational research projects which hold the promise of directly and “immediately” impacting on their medical well-being, translational research grants have become more in vogue than pure academic research. However, translation research is expensive and requires contributions from both academia and industry.

What do you consider more important?

A) Implementing a more transparent and robust FCOI disclosure policy which may slow down the progress of translational research.

or

B) Maintaining a more relaxed policy that can keep up with the current growth rate in biomedical research but runs the risk allowing research projects to be influenced by industrial strategic interests.

Should Life Saving Research be Stymied by Legalese?

 :: Posted by American Biotechnologist on 06-27-2010

Although the debate rages on regarding the use of embryonic stem cells in medical research, the Obama administration has loosened the government’s grip on stem cell regulation resulting in a 3-fold increase in the number stem cell lines approved for federal research funding.

That is why it is particularly disturbing when the USA Today and Nature News report that the NIH has turned down federal approval for the introduction of 47 embryonic stem cell lines submitted by the Reproductive Genetics Institute (RGI), a
world-renowned provider of fertility treatments including InVitro Fertilization (IVF), Preimplantation Genetic Diagnosis (PGD), and prenatal diagnosis. RGI routinely removes an embryonic stem cell from the embryo for genetic testing and if the embryo is found to carry an inheritable disease, it is not implanted into the patient. As such, RGI is routinely left with embryos that carry genes for various illnesses and whose fate would likely be the wastebasket if they cannot be used for medical research. Certainly sounds like a waste of “potential life” to me. And so, RGI asks patients to sign forms that give consent for “leftover” embryos to be used in medical research and then submits a request to the NIH for federal approval to use these cells in medical research. Cell lines that are not approved by the NIH will not be able to receive federal funding for their research.

So far so good. However, the NIH recently rejected 47 cell lines, not for reasons that we might usually associate with normative medical ethics, rather, the cell lines were rejected because of legal gobbledygook (don’t get me wrong…some of my closest friends are lawyers). The gobbledygook was clarified by the NIH as follows:

“The ACD recommended against approving the lines based on findings of the Working Group under Section IIB of the NIH Guidelines, due primarily to exculpatory language in the consent form for the donation of embryos for research. This use of exculpatory language (when someone is asked to give up or waive any rights they may have) was inconsistent with the basic ethical principle of voluntary consent.”

Huh?

OK, well let’s try to explain. According to the USA Today the “exculpatory” language in the consent form absolved the lab of legal liability for any harm that might come to donors from their donation, forbidden in consent forms by federal rules. Does that make sense? Well…I guess that kind of…slippery slope…transparency…the law should be equally applied to everyone…credibility of the NIH…

BUT…we’re talking about 47 cell lines. 47 wasted embryos. 42 embryos that contained genetic information for debilitating diseases such as Cystic fibrosis, Duchene’s muscular dystrophy and Huntington’s disease. Holy cow! Imagine the information that could have been gleamed from these cells. Imagine the mechanisms of disease that could have been revealed. The government was on board. The cells were in our hand. And along came the legal system….

I’m frustrated. The CEO of RGI has told Nature that he tried to contact the consenting couples to get their signatures but the referring physicians refused to give him the patient’s contact information. RGI’s CEO calls the situation a “nightmare” and I tend to agree.

Don’t you?