Presidential Commission Report on Synthetic Biology (Part 2)

I’m finally getting around to finishing up my summary of the President’s Commission for the Study of Bioethical Issues report on synthetic biology. Part 1 covered the background material about this topic, this part will go over the last chapter where the report presents it’s recommendations for how the federal government should be involved in this field.

The main idea was that there isn’t a lot that the council felt needed to be done differently, at least for right now. This is because it’s still at an early enough stage that most of the regulations in place already can apply. Instead it encourages further monitoring and dialogue on this issue. If this was the only recommendations given I could have easily included this in part 1, but the recommendations were framed around 5 concerns that the report suggested were useful for looking at how any new technology can impact society. These 5 concerns are (1) public beneficence, (2) responsible stewardship, (3) intellectual freedom and responsibility, (4) democratic deliberation, and (5) justice and fairness.

Within each of these areas the report offered several specific recommendations.

Public Beneficence “is to act to maximize public benefits and minimize public harm.” Synthetic biology has potential to bring about significant benefits and should be encouraged, but also care needs to be taken to protect the public from harm that could arise from this technology as well. To balance these issues the report gave 3 recommendations.

  1. The federal government should complete a complete review within 18 months of the federal funding for research in synthetic biology and makes this information publicly available.
  2. The government should continue funding promising research in synthetic biology, along with encouraging private organizations to fund research as well.
  3. Federal Agencies involved in research and the Patent Office should review policies on licensing and sharing information to ensure adequate information is being made available.

Responsible Stewardship “calls for prudent vigilance, establishing processes for assessing likely benefits along with assessing safety and security risks both before and after projects are undertaken.” The reported noted that it won’t be possible to evaluate all risks prior to beginning research, but we need to be aware of possible issues and adapt as new information becomes available. This category made up the bulk of this chapter and included 7 more recommendations.

  1. Coordinate regulation between different agencies. As discussed earlier, there already exist regulations by several different agencies that could oversee research in this field and a new agency to focus solely on synthetic biology is unnecessary at this time. Instead the  government should ensure all these regulations are consistent and periodically make this information public.
  2. There should be assessments of possible risks and identify any gaps in risk assessment within 18 months, followed by ongoing assessments. One important thing the report noted is that the scientific community has been very open in discussing what safety precautions are needed for synthetic biology.
  3. As part of the reviews of safety, there should be ongoing review of the capability for designed organisms to replicate outside of the lab. Ways of limiting this include things like requiring certain nutrients to be provided from the media or inserting “suicide genes” to limit the lifetime.
  4. Additional review of safety should be undertaken prior to any organisms being used outside of laboratory settings.
  5. There should be coordination with international organizations that may play a role in synthetic biology, such as other governments, the World Health Organization, and international bioethics organizations.
  6. Researchers should be required to undergo ethics education to ensure the scientific culture with proper responsibility for behavior.
  7. There should be ongoing review of possible moral objections to this research. The report noted that there seems to be very little objection to current capabilities, but as new technology is developed new objections may arise.

Intellectual Freedom and Responsibility, meaning that “conduct of science must promote the creative spirit of scientists and unambiguously protect their intellectual freedom” while also acknowledging that “the mere fact that something new can be done does not mean that it ought to be done” To give the proper amount of freedom the report gave 3 recommendations

  1. The government should see if any changes to regulations should be made in make individual institutions and researchers responsible for their work. This is easier done for official research such as is being done in academic settings. But the development of something like DIYbiology could create additional challenges for promoting individual responsibility.
  2. There should be periodic assessments of the different risks of types of research. This should acknowledge how standards of responsible research may shift over time. The initial assessment should be completed with 18 months.
  3. Depending on the results of the review from the previous recommendation, the government should consider making certain practices mandatory for all types of research. This comes from the concern that many current regulations apply to federally funded research, but private institutes and small scale DIY research would generally not be subject to the same regulations. It may also be necessary to change rules involving export of material to other counties.

Democratic Deliberation “The principle of democratic deliberation reflects an approach to collaborative decision making that embraces respectful debate of opposing views and active participation by citizens.” Since synthetic biology has the potential to affect all people, the public has a right to take part in determining the policies that relate to this research. To encourage this there were 3 more recommendations

  1. Scientists, policy makers and citizens’ groups should be encouraged to continue exchanges to share perspectives on policy and research with the public.
  2. It is important to ensure accurate information is being presented. The writers of the report noted that the scientists involved in research have been good about avoiding to oversell the significance of their work but were more critical of the way it tends to be presented by the media. It specifically noted phrases like “playing God” or “creating life” that tended to attract lots of attention, but were particularly unhelpful for helping the public understand what synthetic biology actually entails. It suggested that there be some organization like FactCheck.org which could be focused on evaluating media portrayal of synthetic biology. I can definitely see the value of such an organization to deal with science in the media more generally.
  3. It is important for science education to include information about synthetic biology and include both scientific and ethical lessons. Some examples of good approaches it pointed to were the iGEM competition, the Synthetic Biology Project at the Woodrow Wilson Center and project BioEYES.

Justice and Fairness dealt with “ the distribution of benefits and burdens across society.” In particular it noted that it’s not enough to simply consider what benefits synthetic biology can provide, but also who benefits from these advances. The final 2 recommendations dealt with how these issues could be approached. I did notice this section was more abstract than the previous sections, probably due to the difficulty in determining what would be considered fair.

  1. Risks should not be unfairly affect certain groups. One obvious way this applies is to look at how human subjects may be chosen. It also relates to how the technology may impact others if it were released into the environment.
  2. The Executive Office should consider recommendations to ensure commercial production using synthetic biology should not unfairly impact others. This may refer to how the new technology may affect the environment where it’s being used, but also includes ensuring people have access to the benefits.

Overall the approach the commission took seemed to be a good one, recognizing the importance of allowing research in synthetic biology to continue, while also beginning to set up the framework for additional precautions to be taken as the field advances.

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