rDNA Research Discussion

rDNA Research Discussion

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Instructions

rDNA Research Discussion

Help me study for my Biology class. I’m stuck and don’t understand.

(1) Address whether the NIH should fund rDNA research.

(a) State whether the NIH should fund rDNA research. Your answer could be yes, no, or

somewhere in between.

(b) Provide details from the readings and/or lectures to support your stance.

(c) Identify one stakeholder (individual or institution) whom you believe would support

the stance you have chosen.

(d) Tell us why you believe this stakeholder would hold your stance.

(2) Create a counter-argument.

(a) Use specific details from the readings and/or lectures to demonstrate a counter-

argument to the stance you chose above.

(b) Identify one stakeholder (individual or institution) whom you believe would support

this counter-argument.

(c) Tell us why you believe this stakeholder would support this counter-argument.

Policies for Genome Editing Module 4, Lecture 2

Title Slide Welcome to Module 4, Lecture 2: “Policies for Genome Editing.” In the last

lecture, we learned some of the basics of policy and the policy analysis process,

including major differences between policies, politics, and laws. In addition, we learned

that stakeholder analysis is the core of policy analysis, and that it consists of continually

assessing the four I’s of individuals, institutions, interests, and influence. Finally, we

learned that policy analysis includes problem identification, followed by policy

formulation, adoption, implementation, and assessment. In this lecture, we will explore

two case studies in the making of public policies for genome editing. Like in the history

module, these include the advent of recombinant DNA in the 1970s and 1980s and the

rise of CRISPR/Cas9 in the 2000s and 2010s. For each, we will build on the

historical materials to consider how the policy process unfolded at each step, paying

particular attention to the individual and institutional stakeholders and their interests and

influences. We will end the lecture with lessons we can take away from genome editing

that are relevant to science policies overall. So, let’s travel back to the 1970s once

more, in this case exploring the policymaking process for recombinant DNA.

Slide 2: rDNA: Problem Identification & Policy Formulation Now, we have already

addressed the process of problem identification in the early history of rDNA policy. In

the history module, we learned that the first rDNAs emerged from the labs of Paul Berg

and Stanley Cohen of Stanford and Herbert Boyer of UCSF around 1973.

We saw that these technologies arose from studies of bacterial systems, and that in the

1970s there were concerns regarding whether rDNA presented undue risks to the public

and scientists and whether technologies derived from rDNA were patentable in the US.

In 1974, biologists enacted a voluntary moratorium on rDNA research until the risks

could be more fully assessed and the NIH could consider policies to help mitigate these

risks.

By the late 1970s, the moratorium had been lifted, concerns over biohazard had calmed

down, and the patentability of rDNA inventions had been confirmed by the granting of

the first Cohen-Boyer patent in 1980.Thus, this context provides us with the main

problem for policy regarding rDNA in the 1970s. Scientists wanted to pursue the

potential benefits of rDNA research, but the perceived risks were real, so biologists

required policy guidance to move forward.

We also learned in the history module that in 1976, the NIH issued the first version of its

“Guidelines for Research Involving Recombinant DNA.” Yet, we stopped the story there

for the most part. So, where did these policies come from, and how did they affect

research? It is to these issues that we now turn. Perhaps the most important figure in

the policy formulation process was Paul Berg, the biochemist who produced the very

first rDNA molecules and whom we have already met. In 1973, at a research

conference, a group of biologists including Berg decided that the advice of the National

Academy of Sciences was imperative before rDNA work could continue. The

2National Academy of Sciences, or the NAS, is an advisory body providing advice to the

federal government. In his capacity as chairman of the NAS committee convened to

investigate rDNA, in 1974 Berg co-authored one of the readings for this week: an article

in Science magazine that laid out “potential biohazards of recombinant DNA molecules.”

These hazards centered around the use of the bacterium, E. coli, as a vector for cloning

rDNAs. Because E. coliresides in the human gut, the fear was that recombinant DNAs

spliced into bacteria might escape the lab and share genetic information with bacteria in

the human digestive tract, potentially resulting in the spread of new kinds of antibiotic

resistant bacteria or even cancer-causing viruses.

The main conclusions of the Science piece were that a research moratorium was

necessary; that even after the moratorium, scientists should be hesitant about making

antibiotic-resistant plasmids that did not already exist in nature; and that an oversight

committee, guidelines, and an international meeting of stakeholders were all necessary

to discuss the next steps. Each of these things took place, providing the core of policy

formulation for rDNA. We will focus on just the international meeting now, before moving

on to policy adoption. In February of 1975, the International Congress on Recombinant

DNA Molecules unfolded at the Asilomar Conference Center in Pacific Grove,

California. The meeting received funding from the NIH and NAS and was organized by

Berg alongside four other biologists, including Maxine Singer at the NIH. Now hailed as

one of the most important meetings in the history of biology, Asilomar was convened to

consider whether the moratorium on rDNA work should end and, if so, what

mechanisms of containment should be recommended to reduce the risks of biohazards.

This week, you will read about the strategies the Asilomar attendees agreed to in their

1975 “summary statement,” including the use of state-of the art fume hoods as physical

blocks during research and special plasmids that could not replicate outside the lab.

In addition, in this 2017 video by the NIH Office of Science Policy, we observe some of

the Asilomar participants discussing the biological issues in 1975. So, to summarize

what we have learned thus far, the problem identification and policy formulation phases

for rDNA in the 1970s left several options for policymaking agencies such as the NIH to

adopt, demonstrating that science policies are both collective–they respond to

competing interests–and historical, in that they respond to the needs of stakeholders at

given points in time.

Slide 3: rDNA: Policy Adoption, Implementation, & Assessment

So, what did agencies such as the NIH do in response to Asilomar? And why is this

case study relevant for genome editing policy today? Well, we can now return to the

1976 “Guidelines for Research Involving Recombinant DNA,” which appeared in the

Federal Register on behalf of the NIH on July 7, 1976. The cover page in the Register

appears on the right-hand side of this slide. As it turned out,

these guidelines incorporated most of the consensus points the scientists had agreed

upon at Asilomar, for instance with regards to biological and physical containment of

rDNA-based hazards. In turn, the NIH reserved the right to withhold its funds from

investigators not adhering to the guidelines, even if the guidelines did not have the force

of law or statutory regulations such as those from the FDA. What’s more, in keeping

with the 1974 “hazards” article and the 1975 consensus statement from Asilomar, the

NIH Director established a Recombinant DNA advisory committee, known as the RAC,

in 1975. The job of the RAC was to provide oversight on grant applications and ongoing

3work, ensuring that all NIH-funded projects followed the guidelines. Working on the

advice of the Asilomar workshop, members of the RAC authored the 1976 guidelines.

The implementation and assessment of the NIH guidelines, in turn, have been flexible

and ongoing. The RAC itself existed until 2019, when the NIH disbanded it in place of

the Novel and Exceptional Technology and Research Advisory Committee. This new

committee provides the same functions as the RAC, but its jurisdiction includes a

broader range of emerging bio-technologies such as CRISPR. The RAC and its

successor have also always coordinated their oversight with the FDA in its regulation of

human subjects research for the development of new medicines. This coordination

continues to be a part of NIH policy, for instance with regards to the degree of oversight

it has over Human Gene Transfer Research, or the transfer of genes into humans using

rDNA. As for the NIH Guidelines, they continue to be revised given new methods and

stakeholder concerns. And as shown on the left-hand side, in 2017 the NIH held a

meeting to honor the continued relevance of the Guidelines and solicit further

stakeholder input, leading to a revision in April 2019. So, to summarize, science policies

are flexible in addition to being collective and historical. Finally, in Berg’s 2008 review of

Asilomar, you will read more about the stakeholders in the rDNA story. These included

scientists, who wanted to continue work in this field but also to act ethically. People

outside the lab were also stakeholders, as they stood to gain from the applications of

rDNA but also to suffer in the events of biohazards. The many journalists present at

Asilomar helped keep the public apprised, and some non-scientists attended the

meeting. Finally, there was the NIH itself, the leaders of which aimed to advance public

health without doing undue harm. Many of these lessons spill over into the making of

policies for CRISPR genome editing, and it is to these that we now turn.

Slide 4: CRISPR: Problem Identification & Policy Formulation

So, how have public policies been made with regards to CRISPR genome editing? And

how have these policies related to other issues, such as rDNA? As it turns out, many

similarities exist between the two cases, even as problems related to CRISPR are still

emerging and being hotly debated by scientists, policymakers, and the public. So, we

will address the processes of problem identification and early policy formulation for

CRISPR first, before turning to the adoption, implementation, and

ongoing assessment of policies for genome editing. Now, some of the policy problems

that arise with CRISPR were also discussed in the history module. The scientific

possibilities associated with the precise, reliable, double-stranded DNA breaks CRISPR

makes possible are vast, as evidenced by Doudna and Charpentier’s Nobel Prize in

2020. Yet, as with rDNA, the full scope of the implications of applying CRISPR to

human subjects is for the most part unpredictable. Thus, policy guidance is needed to

proceed with certain types of research. In the US, as we saw in Jennifer Doudna’s 2015

TED Talk, biologists have called a moratorium until further notice on heritable human

genome editing, presenting another parallel to rDNA. In addition, to address the policy

problems and some solutions, a meeting was held. Doudna and two other biologists are

shown at the right here at the first “International Summit on Human Genome Editing,”

held in Washington, DC in 2015.At this meeting, the policy formulationprocess was

advanced, as 500 people from 10 nations and 3000 more online convened with funding

from the US National Academies of Science and

4Medicine, the British Royal Society, and the Chinese Academy of Sciences. A major

output was the 2017 report on the left-hand side of this slide: Human Genome Editing:

Science, Ethics, and Governance. In particular, Chapter 2 explores oversight of human

genome editing and overarching principles for governance, including existing policy

frameworksthat apply to new human genome editing technologies such as CRISPR.

Slide 5: CRISPR: Policy Adoption, Implementation, & Assessment

So, what is in this report? Well, the report clearly delineates between somatic, or

supposedly non-heritable, and germline, or heritable, human genome editing, which we

saw in Module 2. One of the most important conclusions is that existing policy and

regulatory frameworks from the NIH and FDA will likely prove sufficient for the

governance of most somatic applications of CRISPR. The report reminds us that the

NIH’s original rDNA Advisory Committee, which was re-named in 2019, still fosters

public discussion and oversight. The rDNA Guidelines apply, too. In addition, human

subjects research including for gene transfer therapy and somatic gene therapy–which

really means, any method of altering somatic genes–all falls under the FDA’s

regulations. Thisis also true for research on human gametes, embryos, and fetal

tissues, where the NIH has some oversight as well, for instance through

its Guidelines for Human Stem Cell Research.Overall, however, as the Box 2-1 at the

right here shows, the report concludes that 7 principles should govern human gene

editing research, as new policies are implemented and assessed. These overlap with

bioethical principles, such as the principle of due care, which states that all clinical trials

should proceed with evidence and deliberation. The ethical principle of respect for

persons, in turn, is the idea that all human subjects have equal moral value. Finally, as

the NIH Director’ statement in 2015 noted, the NIH at this time is not funding research

involving heritable human genome modification–in accordance with FDA regulations.

The NIH is, however, funding research on basic biological and somatic cell applications

of genome editing, and it keeps tabs on policy issues in a website shown on the left-

hand slide of this slide. If we were to add more stakeholders to our discussion after

studying the NIH’s more recent genome editing policies, these would include the FDA,

which has statutory authority to regulate the products of gene therapy as drugs. Another

stakeholder is the human research subject, who has protections under the law and

stands to accrue benefit and/or harm from genome editing research.

Slide 6: Lessons

So, what lessons can we learn from these two case studies in genome editing policy?

Well, the first is that policies are collective: They represent competing interests and are

the result of the work of many. Second, policies are flexible: they can be amended to fit

the circumstances of their specific times and places. Third, and finally, policies are

historical. They change through time, are context-dependent, and influence one

another. These things are as true for genome editing policies as they are for all science

policies, including those that the federal administrations may prioritize in the years to

come

rDNA Research Discussion

RUBRIC
Excellent Quality 95-100%	Introduction 45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.		Literature Support 91-84  points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.			Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met.
Average Score 50-85%	40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided.		83-76  points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration.			52-49  points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met.
Poor Quality 0-45%	37-1 points The background and/or significance are missing. No search history information is provided.		75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration.			48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met
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