The US National Institutes of Health has set out new requirements for researchers seeking government grants for human fetal tissue research.
Scientists seeking research grants from US government funding for the use of fetal tissue will need to prove that no alternative approach exists to achieve the same research aim. They will also need to detail how they will obtain approval from the women from whose elective abortions the fetal tissue will come, and explain how the tissue will be disposed of.
'This decision is all about the politics, not about the science, and it has unfortunately allowed the abortion debate to creep into what should be a research issue,' said Lawrence Goldstein, Professor of cellular and molecular medicine, at the University of California, San Diego.
The rule changes follow an announcement in June 2019 from the US Department of Health and Human Services (HHS) that scientists employed by the NIH would cease using human fetal tissue sourced from elective abortions in research.
'Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,' said the HHS.
Following the new application process, research proposals will then be scrutinised by ethics advisory boards which will carry out an additional form of review. Details of the boards are still vague but will apparently contain 'scientists, bioethicists and others'.
Graduate and postgraduate students receiving NIH training funds will no longer be allowed to propose research involving fetal tissue.
The new rules have caused widespread criticism and concern among researchers in the medical and scientific community. A letter expressing 'collective and strong opposition' was sent by 93 medical associations and universities to the Health and Human Services Secretary in July.
'This adds to yet another set of barriers beyond the ones we are already faced with', Heather Pierce, senior director for science policy and regulatory counsel at the Association of American Medical College told CNN. 'That may mean that we are not going to get this important research on terrible diseases like Alzheimer's, macular degeneration and Zika.'
The new restrictions come into force on 25 September 2019, and will not affect studies that have already had grants approved. Studies not receiving government funding will not be impacted.