Ethical, Legal, Social, and Policy Challenges

In addition to numerous scientific and technical challenges, synthetic biology raises questions for ethics, biosecurity, biosafety, health, energy and intellectual property. To date, key stakeholders have focused primarily on the so-called dual-use challenge. For example, while the study of synthetic biology may lead to more efficient ways to produce medical treatments (e.g. against malaria), it may also lead to synthesis or redesign of harmful pathogens (e.g., smallpox) by malicious actors.[citation needed]. Proposals for licensing and monitoring the various phases of gene and genome synthesis began to appear in 2004. A 2007 study by the J. Craig Venter Institute, MIT, and CSIS compared several policy options for governing the safety risks associated with synthetic biology. Other initiatives, such as OpenWetWare, diybio, biopunk, biohack, and possibly others, have attempted to integrate self-regulation in their proliferation of open source synbio projects. However the distributed and diffuse nature of open-source biotechnology may make it more difficult to track, regulate, or mitigate potential biosafety and biosecurity concerns. An initiative for self-regulation has been proposed by the International Association Synthetic Biology, which held a workshop on technical solutions for biosecurity in synthetic biology. The report[5] emerging from the workshop proposes a set of measures to be implemented by the synthetic biology industry for improved biosecurity and biosafety. Deliberate misuse aside, harm to human health or the environment could potentially result from error (e.g. failure to follow standard laboratory containment protocols).

Online discussion of so-called “societal issues” online at OpenWetWare, at the SYNBIOSAFE forum on issues regarding ethics, safety, security, IPR, governance, and public perception (background document).

Some efforts have been made to engage social issues “upstream” focus on the integral and mutually formative relations among scientific and other human practices. These approaches attempt to invent ongoing and regular forms of collaboration among synthetic biologists, ethicists, political analysts, funders, human scientists and civil society activists. These collaborations have consisted either of intensive, short term meetings, aimed at producing guidelines or regulations, or standing committees whose purpose is limited to protocol review or rule enforcement. Such work has proven valuable in identifying the ways in which synthetic biology intensifies already-known challenges in rDNA technologies. However, these forms are not suited to identifying new challenges as they emerge[6], and critics worry about uncritical complicity[7]. An example of efforts to develop ongoing collaboration is the “human practices” component of the Synthetic Biology Engineering Research Center (SynBERC), an NSF funded collaboration among a number of leading research universities. In Europe, the multi-partner project SYNBIOSAFE, coordinated by IDC[8], is investigating the biosafety, biosecurity and ethical aspects of synthetic biology. The International Consortium for Polynucleotide Synthesis was formed in 2006 to encourage sharing of ideas and resources for pro-actively monitoring synthetic gene orders and enforcing safe practices, (ICPS). The recently formed Industry Association Synthetic Biology (IASB) has also started to tackle open biosecurity problems for biotech companies doing gene synthesis.

A report from the Hastings Center and Woodrow Wilson Center found that non-physical moral concerns in synthetic biology have received scant attention. Distributive justice and our relationship with nature are two such concerns. The authors suggest that what is needed most is a better understanding of precisely what values are considered at play in the context of synthetic biology.

In January 2009, the Alfred P. Sloan Foundation funded the Woodrow Wilson Center, the Hastings Center, and the J. Craig Venter Institute to examine the public perception, ethics, and policy implications of synthetic biology.

“Ethics is a body of principles or standards of human conduct that govern the behavior of individuals and groups” (Bottorff, n.d., p.1). “While ethical behavior is based on a set of values and principles, ethical behavior goes beyond mere belief; it also encompasses actions of individuals, groups and organizations (p. 2). Ethics encompasses “the principles, norms, and standards of conduct governing an individual or group” (Trevino and Nelson, 2003, p. 13). Ethics can be considered a set of standards that an individual or organization uses to guide actions of the individual or group. Corporate social responsibility “is about how companies manage the business processes to produce an overall positive impact on society”

A socially conscious organization recognizes its responsibilities on several different levels, including; economic, legal, ethical and philanthropic responsibilities (Trevino and Nelson, 2003, p. 31). Therefore, ethical behavior can be seen as one aspect of a socially responsible company. A company cannot be socially responsible if it only looks after its economic and legal responsibilities. There are times when a company must do more than what is required by the letter of the law and consider what is ethical. This is especially true for multi-national organizations that operate in countries with varying legal responsibilities. The company must be driven by ethical standards above and beyond bare minimum legal requirements.

Just as ethical behavior is a part of a socially responsible organization; it is difficult to imagine a company that is striving to be ethical, not to become socially responsible. As a company examines its ethical actions, they will be driven to make decisions that become more socially responsible. This is especially true as the company strives to provide ethical treatment to all stakeholders beyond shareholders. If employees and community are considered in the decision making process as stakeholders, then decisions will be made in ways to reduce negative and enhance positive outcomes for each group. Hence, the company’s actions become more and more socially responsible.

Ethical behavior then is one component of a social responsible organization. If the organization or leader strives for social responsibility, they will be driven to act more and more ethically toward all stakeholders. Likewise, an ethical leader or organization will become more socially responsible as they consider making decisions through an ethical lens.

Since founding Magnify Leadership and Development, James has developed, facilitated and coached programs including; Change Leadership, Coaching, Communication Skills, Sustaining Learning, Interviewing Skills, Leadership, Territory Management for dozens of leading global organizations; including, Advantis Research and Consulting, IMS, CMOE, Pfizer, Sinclair, Disetronic Medical Systems, StratX, ASTD, Coventry Health Care, Wilson Learning, and many others. James is bilingual and can facilitate and coach in both English and Spanish.

Prior to founding Magnify Leadership and Development, James headed Pfizer’s Learning and Development for all of Europe, Canada, Africa and the Middle East where he was instrumental in the development of a global management curriculum and other training initiatives to enhance organizational effectiveness for over 30,00 employees.

Organ Donating – The Moral, Ethical, and Legal Stalemate

The act Donating Organs, either prior to death or after death, is considered by many to be one of the most generous, selfless and worthwhile decisions that one could make. The decision to donate an organ could mean the difference of life or death for a recipient waiting for a donor. Organ donations offer patients new chances at living more productive, healthy and normal lives and offers them back to families, friends and neighborhoods.

Despite the increasing number of donor designations in the past few years, a shortage still exists in donors. There are nearly 100,000 people waiting patiently on organ transplant waiting lists, but sadly, on an average day, less than 80 people receive donor organs and approximately 19 die waiting for transplants. Even with the success rates of transplants improving almost 4500 new patients are added to the waiting list every month.

In general there have been a number of issues that have stood in the way of the success of organ donation, and in so far as to say they are trivial, many believe that they resolve to basic human emotions. Many might think that ethical beliefs in what is right or wrong, good or bad, necessary or unnecessary, shouldn’t play a role in life or death. But what about the moral obligations that we share as human beings to protect life?

It is differences in moral and ethical beliefs along with political and legal positions that have stood in the way of the progress of organ donation. Politicians, Doctors, Lawyers, all offer many thoughts on what is right and what is our duty. What is the right thing to do? Are Doctors obligated to give a good liver to an alcoholic? Is is right to accept an organ from an impoverished person who sells their organs for money. How about the mentally or physically challenged? Can we harvest organs from those who cannot and will not be fully able to use them? What about those that are incarcerated with no chance of parole? How about allowing a convicted murderer his sight back, should this person be allowed to be a recipient? There are many, many moral and ethical questions that may never be answered to clear the path for organ donating.

Among all the moral, ethical, physical, and medical viewpoints there are also religious ones as well. While almost all religions agree that organ donations are acceptable and individual members can make their own decisions, there are some restrictions. Jehovah’s Witnesses allow only for organs that have been completely drained of blood due to the belief that transfusions are disallowed in the Bible. The Muslim religion absolutely demands that there be prior written consents before an organ transplant takes place. Orthodox Judaism claims it is necessary and proper if a life can be saved to perform an organ transplant as long as the donor is proclaimed dead as defined by Jewish law. The Shinto religion and the customs of the Gypsies are two notable groups that disallow transplantation.

Because of the sever shortages in donor organs there are also very difficult decisions that need to be determined during the screening process. Deciding who is eligible is not an easy task by any means. Factors such as organ viability (how long an organ can last outside the human body) can drastically reduce the number of patients that can be considered for a transplant, because the patient has to be in relatively close proximity to the organ. Sex, age, race, physical condition, blood type, tissue type, body size, blood antibody levels, all play a role in the determination for selection of potential donors. Many hospitals now have organ network representatives who will screen potential donors prior to death, requesting tests, requesting organ preserving drugs, and obtaining the proper legal documentation and family consents. These actions have all contributed to the increase in transplant efficiency.

Becoming and organ and tissue donor could be the best thing you’ve ever done. Each organ and tissue donor saves or improves the lives of as many as 50 people. Registering with your state donor registry is the first step to becoming an organ donor. Designate your decision on your driver’s license, and sign a donor card and carry it with you. And, most importantly, talk to you family and inform them of your decision so they will be prepared when the time comes.

“This article is brought to you by Gus Woltmann”.