First, describe a biological engineering application or tool you want to develop and why. This could be inspired by an idea for your HTGAA class project and/or something for which you are already doing in your research, or something you are just curious about

  1. Next, describe one or more governance/policy goals related to ensuring that this application or tool contributes to an "ethical" future, like ensuring non-malfeasance (preventing harm). Break big goals down into two or more specific sub-goals.** Below is one example framework (developed in the context of synthetic genomics) you can choose to use or adapt, or you can develop your own. The example was developed to consider policy goals of ensuring safety and security, alongside other goals, like promoting constructive uses, but you could propose other goals for example, those relating to equity or autonomy.

Next, describe at least three different potential governance "actions" by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”). Try to outline a mix of actions (e.g. a new requirement/rule, incentive, or technical strategy) pursued by different "actors" (e.g. academic researchers, companies, federal regulators, law enforcement, etc). Draw upon your existing knowledge and a little additional digging, and feel free to use analogies to other domains (e.g. 3D printing, drones, financial systems, etc.)

Next, score (from 1-3 with, 1 as the best, or n/a) each of your governance actions against your rubric of policy goals. The following is one framework but feel free to make your own

Last, drawing upon this scoring, describe which governance option, or combination of options, you would prioritize, and why. Outline any trade-offs you considered as well as assumptions and uncertainties. For this, you can choose one or more relevant audiences for your recommendation, which could range from the very local (e.g. to MIT leadership or Cambridge Mayoral Office) to the national (e.g. to President Biden or the head of a Federal Agency) to the international (e.g. to the United Nations Office of the Secretary-General, or the leadership of a multinational firm or industry consortia). These could also be one of the “actor” groups in your matrix.

Reflecting on what you learned and did in class this week, outline any ethical concerns that arose, especially any that were new to you. Then propose any governance actions you think might be appropriate to address those issues. This should be included on your class page for this week.

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Ray’s answers

"My project, is creating a personalized medicine tool that leverages the extensive genetic information obtained from 32AndMe to create personalized awareness information sheet to the risk of adverse reactions. I intend to use existing open source repositories of medical and anonymized patient information.

Governance/Policy Goals

  1. Safety: Ensure that the personalized medicine tool is safe for use and does not cause harm to patients.Sub-goal 1: Establish rigorous testing and validation processes to verify the accuracy and reliability of the genetic information used in treatment decisions.
  2. Equity: Guarantee fair and equal access to the benefits of personalized medicine, regardless of socioeconomic status or geographic location.Sub-goal 1: Develop policies to address potential disparities in access to genetic testing and personalized treatments, particularly for underprivileged communities.

Potential Governance Actions

  1. Purpose: Regulatory requirement for comprehensive safety testing and validation of genetic information used in treatment decisions.: 2 (meets safety goal), 3 (may create barriers to innovation and access if overly burdensome)
  2. Design: Incentivize companies to invest in research for rare diseases and underrepresented populations.: 3 (supports equity goal), 1 (may lead to neglect of common diseases with larger markets)
  3. Assumptions: Federal regulators collaborate with academic researchers to establish best practices for monitoring and reporting personalized treatment outcomes.: 2 (supports safety goal), 2 (may be challenging to implement due to resource constraints)

These governance actions are scored based on their alignment with the policy goals of safety and equity. Each action is evaluated against the specific sub-goals to assess its potential impact.

The search results did not provide direct information related to biological engineering applications or governance actions in this context. Therefore, the response is based on existing knowledge and expertise in the field of biological engineering and healthcare policy. If there are specific regulations or frameworks in place, they should be considered when developing governance actions for a new biological engineering application.