EXECUTIVE SUMMARY

Updated guidelines on stem cell research from the International Society for Stem Cell Research are expected to alleviate some long-standing ethical concerns. The guidelines include the following:

  • Sanction research involving human embryos, provided certain conditions are met.
  • Sanction reasonable compensation for women who provide eggs for research.
  • State that stem cells should demonstrate safety and efficacy in rigorous trials before they are commercialized or offered to patients outside of trials.

Updated guidelines on stem cell research from the International Society for Stem Cell Research may alleviate some long-standing ethical controversies.

“The guidelines make some moral choices. If everyone agreed with every recommendation we offered, it would be a sure sign that guidelines aren’t needed,” says Jonathan Kimmelman, PhD, who runs the Studies of Translation, Ethics, and Medicine (STREAM) research group and is associate professor in the Biomedical Ethics Unit at Montreal-based McGill University.

Previous guidelines, released in 2006 and 2008, focused on embryonic stem cell research and on clinical translation of stem cell research. The 2016 guidelines cover all research on human embryos, including controversial gene editing.

“Our hope is that they reduce uncertainty about appropriate conduct in laboratory and clinical investigations involving stem cells,” says Kimmelman.

The guidelines articulate benchmarks and expectations about appropriate research conduct. “This may allay concerns that members of the public, governments, and scientists might have about stem cell research,” says Kimmelman. The following are some issues addressed by the guidelines:

  • The guidelines sanction research involving human embryos, provided certain conditions are met.
  • They sanction reasonable compensation for women who provide eggs for research.

“The guidelines will not necessarily assuage concerns among religious communities who believe embryos should never be used in research, or among individuals who would ban any compensation for egg procurement,” notes Kimmelman.

  • The guidelines state that stem cells should demonstrate safety and efficacy in rigorous trials before they are commercialized and/or offered to patients outside of trials.

“Those favoring unfettered access to unproven cell-based interventions — and clinics that turn a profit doing so — will likely chafe at our recommendations,” says Kimmelman.

The guidelines address some ethical issues that are already largely resolved. For example, requiring that patients who have decisional capacity give consent before they are enrolled in trials of cell-based interventions, or that such trials undergo prospective ethical review, is almost universally accepted.

“It is relatively uncontroversial to say that all research involving human embryos and stem cells should undergo an embryo research oversight process,” says Kimmelman.

There is also a general consensus that clinics should not market unproven cell-based interventions to patients. Instead, they should first rigorously evaluate them in the context of well-designed trials, he says.

“There are a number of issues that will likely present challenges, and for which greater guidance will be needed,” says Kimmelman.

One such area is self-organizing tissues — embryonic tissue that, under certain conditions, can organize into embryo-like structures. “Since such structures have not undergone embryonic development, it can be unclear on where to draw the line between acceptable and unacceptable research activities,” says Kimmelman.

There are also implementation challenges. For instance, saying that clinics should not market unproven cell-based interventions to patients is one thing — enforcement is another matter.

“The same goes for asking scientists to provide balance, and to remain circumspect, when they report their findings to the public or in scientific articles,” Kimmelman says.

SOURCE

  • Jonathan Kimmelman, Associate Professor, Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Phone: (514) 398-3306. Fax: (514) 398-8349. Email: jonathan.kimmelman@mcgill.ca.