Bioethics - Research Ethics

What are the three issues in research ethics?

Funding, Topic, and Subject

Funding Issues

private vs government funding and ownership of research. Potential bias, conflicts of interest, and transparency in funding.

WW2 Impact on Science Funding

Science research received a massive boost during WW2 because it was focused on the war effort.

Vannevar Bush

set the plans in place to establish the NSF, NIH, and other agencies for scientific development

Who started the HGP?

Started by Robert Sinsheimer and picked up by Charles Delisi, the director of OHER and DOE.

How did Delisis support the HGP?

Charles Delisis had government connections and was able to allocate fundings from himself and congress to the project.

Who boosted the HGP? How?

Renato Dulbecco wrote an article for Science advocating for the project and its uses in cancer research.

Goal of the HGP

Map the entire genetic complement of human beings.

Objections of the HGP

1. small fraction of genome codes for actual genes

2. repitious and tedious

3. discovery-driven

4. limited resources

5. DOE may not be the best for the job

Outcomes of the HGP

1. NIH was given the lead and formed the National Center for Human Genome Research lead by James Watson.

2. Forced to invent bioinformaatics to manage data that was far more complex than originally expected

3. Established that time must be heavily considered in ethics with regard to research science, ethics cannot be an afterthought

4. Posed issues in privacy, discrimination, and prenatal genetic testing

5. Watson established the ELSI to consider ehtical, legal, and societal implication issues

6. Bermuda conference decided HGP would fall under the Public Domain (able to be used by anyone)

Stanford vs Roche

Bayh-Dole act granted Roche company rights to Stanford’s invention research. Stanford sued, but Roche won.

Pros and Cons of Patents

1. Pros - ownership drivers innovation and working around patents also drives innovation

2. Cons - ownership drivers innovation and working around patents also drives innovation. Cons include owners may make access impossible and too broad a claim can cause a back up in innovation

Negative and Positive Rights of Patents

Patents grant negative rights, it prevents other from interfering with your property. Positive right is that the holder is granted no oblication to change laws to ensure it can be used, nor any help as far as producing the invention.

Gene Patents and HGP

Mapping the human genome could fall under a patent discovering a composition of matter or a copyright for the presentation of the information.

Venter and HGP

Craig Venter filed patents on genetic sequences then formed Celera where he would allow limited access to the information. Issue with fairness- scientists argued that Venter had accesss to all the previous work but would not reciprocate leading to transfer of ownership of the human genome.

Funding Issue HGP

If private companies should do it, why should the governments pay for it?

Competence Issue HGP

the shotgun method would lead to an incomplete map… but the patents would stop others from improving it. shotgun method was fragmenting the genome, cloning the fragments, and sequence it with computer programs.

Success of HGP

HGP completed its work under budget and ahead of schedule. It lead to technological advancements in computing and the creation of thousands of smaller biotech companies.

HGP Challenges

1. lack of understanding for sequenced genomes

2. unsure of which specific genes define humans from other species

Association for Moecular Pathology v. Myriad Genetics

SCOTUS unanimously ruled that naturally occuring human genes could not be patented, although synthetic versions of genes could be patented.

Topic Issues

1. How do you figure out what to study?

2. What is owed to those who help?

Canavan Disease Case

1. Dan Greenberg cinvinced Malton to study the Canavan Disease. They got funding from the NTSAD.

2. Malton discovered the cause of Canavan disease which produced a prenatal screening test and alowed Greenbergs to give birt to a child without the disease.

3. Malton moved to MCH.

4. Screening was inefficient with 4/19 couples still having children with the disease.

5. Guangping Gao found the gene responsible for the disease for better screening. MCH got a patent for the gene.

6. Efforts to commercialize drug unsuccessful. MCH got criticism.

7. Dan and families sued MCH and claim accepted on the equitable doctrine of unjust enrichment - MCH profited unfairly.

8. MCH settled. MCH ownership was not challenged and gene free to use.

Equitable doctrine of unjust enrichment

1. plaintiff must have offered something of value with the expectation of getting something in return

2. defendent must have acknowledged, accepted, and benefited from what the plaintiff provided

3. plaintiff must show that it would be inequitable for the defendant to benefit without paying

Subject Issues

Conflict between utility and patient/subject care

indirect complicity

if a first outcome is achieved from an immoral act, every subsequence outcome carries the taint of that immoral act. (artwork thatthe Nazi’s stole in WW2 as an example, it would be immoral for someone to keep the painting)