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In the Societies: Professional Ethics Report Spring 2016

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Cell Research (ISSCR) Issues New Research Guidelines
by Claire Sabel

The ISSCR, the world’s largest professional organization of stem cell researchers, published revised guidelines for research and clinical translation involving stem cells on May 12, 2016. [1] The new guidelines update and combine guidelines on stem cell research and clinical translation previously issued in 2006 [2] and 2008 [3].

Jonathan Kimmelman, Associate Professor of Biomedical Ethics at McGill University, chaired the ISSCR Guidelines Update Task Force. The group was made up of 25 experts in basic research, clinical research, and bioethics, and received feedback from 85 external individuals and organizations.

The 2016 guidelines cover new ground in areas such as gene editing and induced pluripotent stem cells, and introduce a new focus on the communication of results. The task force recognized that results and potential applications can be exaggerated, leading to distorted understandings of research outcomes in the scientific community, popular press, and among potential patients. [4] The “14-day rule” limiting experimentation on human embryos or embryo-like structures is upheld in these guidelines, although one task-force member has elsewhere suggested that this too may soon be open to revision. [5]

ISSCR released the following list of all of the new topics addressed in the revised guidelines as part of the announcement of its report [6]:

  • Define an Embryo Research Oversight (EMRO) process to encompass both human embryonic stem cell research and human embryo research that may not explicitly pertain to stem cells or generating new stem cell lines; 
  • Exclude the generation of induced pluripotent stem cells (iPS cells) from specific stem cell research oversight, and instead call on the existing human subjects review processes to oversee donor cell recruitment (iPS cells behave like embryonic stem cells but are derived by reprogramming more differentiated tissue cells);
  • Support laboratory-based research that entails gene editing of the nuclear genomes of human sperm, egg, or embryos, when performed under rigorous review, but hold that any attempt to apply this clinically would be premature and should be prohibited at this time; 
  • Define principles for evaluating both basic and clinically applied research on mitochondrial replacement therapy, in concordance with recent deliberations in the U.K., U.S., and elsewhere; 
  • Determine that where there is no undue financial inducement to participate, it may be acceptable to compensate women who donate eggs for research; 
  • Recognize that the development of increasingly complex in vitro models of early stages of human development should undergo specialized review; 
  • Highlight opportunities to strengthen preclinical studies in stem cell research, including reproducibility and stringent standards for experimental design; 
  • Call for robust standards for preclinical and clinical research evidence as clinical trials progress and rigorous evaluation for safety and efficacy before marketing approval; 
  • Address the valuable contributions made by patients or patient groups to support clinical research and a framework to ensure this is achieved without compromising the integrity of the research; 
  • Highlight the responsibility of all groups communicating stem cell science and medicine—scientists, clinicians, industry, science communicators, and media—to present accurate, balanced reports of progress and setbacks. 

[1] http://www.isscr.org/docs/default-source/guidelines/isscr-guidelines-for-stem-cell-research-and-clinical-translation.pdf?sfvrsn=2
[2] http://www.isscr.org/home/publications/guide-clintrans
[3] http://www.isscr.org/home/publications/ClinTransGuide
[4] http://science.sciencemag.org/content/352/6287/776
[5] http://www.nature.com/news/embryology-policy-revisit-the-14-day-rule-1.19838
[6] http://www.isscr.org/home/about-us/news-press-releases/2016/2016/05/12/isscr-releases-updated-guidelines-for-stem-cell-research-and-clinical-translation 


AAAS Urges Policy Makers to Support Ethical Fetal Tissue Research
by Claire Sabel

In a letter to the Select Investigative Panel of the House Energy and Commerce Committee (the Panel) on April 25, 2016, the CEO of AAAS, Rush Holt, described the important role of fetal tissue in medical research. [1] The letter emphasized that science is unpredictable, and therefore “by limiting the scope of research and restricting the scientific community’s ability to follow the evidence, we thereby limit the possibility of discovering new medical advances, vaccines, or cures aimed at bettering society.”

The Panel was created on October 7, 2015, and organized its first hearing, on “Bioethics and Fetal Tissue” on March 7, 2016. [2] On March 17, the Chairman of the Investigative Panel, Marsha Blackburn (R-TN), issued a statement commending two recent studies on potential vaccines for the Zika virus and Dengue fever, neither of which used fetal tissue as the basis for research. The statement suggested that this new research contradicted the claims of the scientific community that the Panel’s investigations would hinder research efforts in these areas. [3]

The current concern about the use of fetal tissue in biomedical research emerged in July 2015, when videos were made public alleging that Planned Parenthood clinics had illegally sold tissue fetal from aborted fetuses. [4] As a result, the Panel has focused largely on alleged transactions related to the supply of fetal tissue for research. Several studies have been halted because of the sharp decrease in availability of fetal tissue since the investigations into fetal tissue suppliers began last year. [5]

Holt’s letter explains that scientists who work with fetal tissue find it to be both “unique and useful” because it can provide information not always available from adult human tissue or animal. While studies on animals may be predictive of effects in humans, Holt states that “fetal tissue is specific to early human development and may provide a level of assurance that may not be found solely utilizing adult or animal tissue.”

The letter goes on to provide historical and contemporary examples of valuable discoveries made using fetal tissues, including the breakthrough polio vaccine in the 1930s, where researchers used infected fetal kidney cells to develop an effective treatment. While fetal tissue proved instrumental in the polio vaccine discovery, it was one type of research used among many to understand the various dimensions of the virus. In ongoing research into the Zika virus, donated fetal tissue allows scientists to understand the effects of the virus in vivo.

This is the second letter that AAAS has sent to Chairwoman Blackburn about fetal tissue research, and in addition to commenting on the efficacy and importance of fetal tissue in medical research, highlights additional concerns raised by the Investigative Panel’s ongoing hearings. [6] Holt points out that many scientists who work with fetal tissue are hesitant to be cited due to safety concerns. When the Panel issued subpoenas to individuals affiliated with the University of New Mexico, including two faculty members whose work involves fetal tissue, UNM declined to provide the names of staff and students who worked on the research in question because of concerns for their safety. [7]

AAAS has expressed concern repeatedly that the Panel’s subpoenas would make the names of researchers and students involved with fetal tissue research public, and affirms its commitment to support and defend scientists who seek to answer important scientific questions in the service of society. AAAS has made resources available on its website that document widespread support of the use of fetal tissue in scientific research within the scientific community, as well as describing ethical issues associated with fetal tissue research. [8]

[1]http://www.aaas.org/sites/default/files/AAAS%20Select%20Panel%20Response%204.25.16.pdf
[2] https://energycommerce.house.gov/news-center/press-releases/select-investigative-panel-hold-hearing-bioethics-fetal-tissue
[3] https://energycommerce.house.gov/news-center/press-releases/blackburn-chides-democrats-exaggerating-importance-fetal-tissue
[4]https://www.propublica.org/article/everything-you-need-to-know-about-the-planned-parenthood-videos
[5]http://www.nytimes.com/2016/03/25/us/politics/house-seeks-names-of-fetal-tissue-researchers-prompting-claims-of-intimidation.html
[6]http://www.aaas.org/sites/default/files/AAAS_FTR_March%202016.pdf
[7]http://www.sciencemag.org/news/2016/04/groups-protest-house-demands-names-fetal-tissue-researchers
[8] http://www.aaas.org/page/resources-issue-fetal-tissue-research 

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Author

Joel Ericsen

Program Assistant