ETHICAL DILEMMAS IN SCIENTIFIC RESEARCHDavid B. Resnik, JD, PhD, NIEHS/NIH

This research is supported by the NIEHS/NIH. It does not represent the views of the NIEHS, NIH, or US government.

What is an ethical dilemma?• A situation in which two or more options (choices) appear

to be equally good (or bad) from an ethical point of view.• You may have to choose between the lesser of two evils

or the greater of two goods.• The main question is not “should I do the right thing?” but

“what is the right thing to do?”• You may feel uneasiness, uncertainty, and stress when

faced with an ethical dilemma.

Ethical dilemmas in scientific research

• Ethical conduct is essential to scientific research, as it promotes collaboration, knowledge advancement, education, and public trust.

• Ethical dilemmas frequently occur in scientific research.• Ethical codes, policies, laws, and other rules may give you

some guidance, but they don’t cover every situation, they sometimes conflict, and they are subject to interpretation.

• Being a responsible researcher therefore involves much more than just following policies and rules. You must also be able to make well-reasoned choices when confronted with ethical dilemmas.

Example 1• Mr. Smith was a graduate student in Dr. Jones’ laboratory. He

was working on isolating an immune system protein for the purpose of studying its relation to inflammation.

• Mr. Smith isolated the protein and was working on an antibody to test for its presence.

• Mr. Smith had a falling out with Dr. Jones and left the laboratory to work with another investigator.

• Dr. Jones assigned Ms. Watkins for continue the project that Mr. Smith was working on. The project is now near completion and they are preparing to submit a paper for publication.

• Mr. Smith finds out about their progress and wants to be author on the paper. Dr. Jones was not planning to include him as an author.

• What should Mr. Smith do? Does he deserve to be an author?

Example 2• Dr. Farrington is an investigator conducting a multisite clinical trial,

sponsored by Big Pharma, that compares Drug A (manufactured by Big Pharma) to Drug B in the treatment of Multiple Sclerosis.

• The initial study plan for data analysis was to use an intent-to-treat approach, i.e. analyzing data from all subjects who enroll in the trial, including those who drop out or are withdrawn.

• Dr. Farrington owns patents on Drug A and receives $300,000 per year in consulting fees from Big Pharma.

• Dr. Faber has been collaborating with Dr. Farrington on this study.• Dr. Faber is distressed to learn that Big Pharma has decided to switch its

data analysis to an on-study approach (analyze the data only for subjects who complete the study), because the intent-to-treat approach was not very favorable to its drug.

• She communicates her concerns to Dr. Farrington, but he is not too worried about this and he thinks the new data analysis plan is fine.

• What should Dr. Faber do?

Example 3 • In 2011, two NIH-funded research teams, one led by Yoshihiro

Kawaoka, University of Wisconsin, USA, and another led by Ron Fouchier, the Erasmus Medical Center, The Netherlands developed methods of genetically modifying the H5N1 avian flu virus so that it can be transmitted between mammals.

• They submitted their papers to Nature (Kawaoka) and Science (Fouchier).

• The virus is highly lethal (mortality rate of 60%) but people can only contract it by coming into contact with birds. Over 300 people have died from the H5N1 since 1997.

• Infectious disease specialists and public health official have been concerned that H5N1 might naturally mutate so that it is more easily transmitted between people.

• The researchers have shown how create these mutations artificially.

Example 3• The NIH asked the National Science Advisory Board for Biosecurity to

review the research. In December 2011, the NSABB recommended that the research be published in redacted form, with key details only available to responsible scientists. They were concerned that the research could be used to make a bioweapon and cause a deadly pandemic.

• In February 2012, a WHO panel recommended publication in full.• In March 2012, the NSABB recommended full publication, after learning

about the importance of the research for surveillance of bird populations for dangerous H5N1 mutations, as well as practical and legal problems with redacted publications. The NSABB also concluded that the mutated virus was as easily transmissible by air as previously thought. 6 out of 18 members did not agree with recommending full publication of Fouchier’s paper.

• In May, Nature published Kawoaka’s paper and Science was in the process of publishing Fouchier’s.

• Do you agree with the decision to publish these papers?

Ethical dilemmas in scienceEthical dilemmas occur in many different aspects of scientific research including:• Authorship• Publication• Data sharing, data analysis, data interpretation• Sharing of research materials • Collaboration• Peer review• Mentoring and teaching• Laboratory management• Research with animal subjects• Research with human subjects• Research for industry• Community-based research• Conflicts of interest• Intellectual property • Reporting misconduct or other violations of policies or laws

How to do deal with ethical dilemmas in research

• Talk to your associates, colleagues, supervisors• Consult with institutional officials, such as a research

ethics officer or ombudsman. • Gather relevant information and documentation.• Take time to think about what to do and avoid rash

decisions (if possible).

A method for ethical decision-making

Here is a method to guide you thinking about what to do:• Identify the ethical issue, question, or problem. • Gather relevant information.• Delineate different options or choices.• Apply policies, laws, and ethical principles to the different

options.• Resolve conflicts between policies, laws, or principles, in

light of the information and options. • Make a decision and act.

Application: H5N1 case• What is the ethical issue, question or problem?

• To publish or not

• What information is relevant to make a decision? What additional information do we need? • Information about the value of the research for science and public health,

risks of the research: could it be made into a deadly bioweapon, how easily?

• What are the options?• Publish in full; don’t publish; redacted publication

• What laws, policies, or ethical principles apply?• Export control laws, journal and NIH dual use review policies; ethical

principles: openness and freedom vs. social responsibility (preventing harm).

• How can one resolve conflicts between laws, policies, or ethical principles?

• What should we do?

Resolving conflicts• Resolving conflicts of principles or other rules is often the

most difficult part of this process. Some fundamental principles of research ethics include:

• Honesty• Openness• Academic freedom• Carefulness• Fair sharing of credit• Respect for colleagues and students• Respect for animal and human subjects• Respect for the law and institutional policies• Social responsibility

Resolving conflicts• The dilemma concerning the publication of the research

on the A(H5N1) virus is a conflict between openness and freedom and social responsibility.

• How should we balance these principles?• The NSABB initially favored social responsibility over

openness and freedom but then changed its mind. Why?• Very often, the application of information to particular

decisions can play a key role in the balancing of principles.

• However, different people may balance principles differently, even when they are presented with the same information.

Resolving conflicts• Utilitarian view: Which option would produce the greatest

balance of good/bad consequences for all people affected? What are the consequences of different options and who would be affected?

• Kantian view: Which option could become a universal rule for human action (which one could not)? Which option is the most rationally defensible?

• Virtue ethics: Which option is most consistent with acting like a morally virtuous person? Which option would make you a better (or worse) person? Can you live (or not live) with yourself if you choose a particular option?

Questions?• Thanks!