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Week 5: Public Health Ethics
Transcript of Week 5: Public Health Ethics
Public Health Ethics
The values that help public health
professionals to act in virtuous ways
The values that help to illuminate hard problems in public health policy and practice
The overarching value of population health and social justice
Week 5 - Public Health Ethics
Centers for Disease Control and Prevention (2012).
Crisis and emergency risk
Centers for Disease Control and Prevention. U.S. Public Health Service Syphilis Study at Tuskegee: http://www.cdc.gov/tuskegee/index.html
Center for Law and Public’s Health at Georgetown and Johns Hopkins
Universities & Centers for Disease Control and Prevention (2001).
The model state emergency health powers act.
Curtis, H. (2014)
Revisiting Jacobson: An Analysis of the Modern Day Implications of Jacobson v. Massachusetts.
Voices in Bioethics.
What is herd immunity?
Retrieved 10/15/2012 from:
Jennings, B., et al (eds).
Ethics and public health: Model curriculum.
Association of Schools of Public Health.
Joint Centre for Bioethics, University of Toronto, Pandemic Influenza Working Group (2005).
Stand on guard for thee: Ethical considerations in preparedness planning for pandemic influenza.
Retrieved 1/29/2011 from: http://www.jointcentreforbioethics.ca/publications/pubhealth.shtml
Louisiana State Law Center. Historic public health cases/vaccine law/police power. Retrieved 1/29/2011 from:http://biotech.law.lsu.edu/cases/vaccines/Jacobson_v_Massachusetts_brief.htm
Mariner, W. et al (2004).
Jacobsen v. Massachusetts: Its not your great-great grandfather's public health law.
American Journal of Public Health.
Nilsen, T. R. (1966).
Ethics of speech communication.
Indianapolis, IN: Bobbs-Merrill.
Public Health Leadership Society, Centers for Disease Control and Prevention, & American Public Health Association.
Principles of the Ethical Practice of Public Health,
Reynolds, B. & Seeger, K. (1995).
Crisis and emergency risk communication as an integrative framework.
Journal of Health Communication.
State of New Jersey, Department of Health. Institutional Review Board: http://www.state.nj.us/health/irb/index.shtml
Thomas, J. Public health ethics (lecture). University of North Carolina, North Carolina Institute for Public Health.
Ulmer, R., Sellnow, T., & Seeger, M. (2007).
Effective crisis communication: Moving from crisis to opportunity.
The beliefs and standards of good and bad, right and wrong, that people actually do and should follow in a society
study of morality
The names for states of affairs that conform to what is ethically right and that further the human good
Ethics applied to decisionmaking and public policy in biology, medicine, and health care
What society does collectively to assure the conditions for people to be healthy
- Institutes of Medicine,
The Future of Public Health
Both relate to health and have some concerns in common, but each also has some unique concerns, reaching where the other circle does not
- Centralized Application Service for Public Health
A social or population
Public Health Code of Ethics
12 Principles of the Ethical Practice of Public Health
Humans have a right to the resources necessary for health.
The Public Health Code of Ethics affirms Article 25 of the Universal Declaration of Human Rights, which states in part “Everyone has the right to a standard of living adequate for the health and well-being of himself and his family…”
Humans are inherently social and interdependent.
Humans look to each other for companionship in friendships, families, and community; and rely upon one another for safety and survival. Positive relationships among individuals and positive collaborations among institutions are
signs of a healthy community. The rightful concern for the physical individuality of humans and one’s right to make decisions for oneself must be balanced against the fact that each person’s actions affect other people.
The effectiveness of institutions depends heavily on the public’s trust.
Factors that contribute to trust in an institution include the following actions on the part of the institution: communication; truth telling; transparency (i.e., not concealing information); accountability; reliability;
and reciprocity. One critical form of reciprocity and communication is listening to as well as speaking with the community.
Collaboration is a key element to public health.
The public health infrastructure of a society is composed of a wide variety of agencies and professional disciplines. To be effective, they must work together well. Moreover, new collaborations will be needed to rise to new public health challenges.
People and their physical environment are interdependent.
People depend upon the resources of their natural and constructed environments for life itself. A damaged or unbalanced natural environment, and a constructed environment of poor design or in poor condition, will have an
adverse effect on the health of people. Conversely, people can have a profound effect on their natural environment through consumption of resources and generation of waste.
Each person in a community should have an opportunity to contribute to public discourse.
Contributions to discourse may occur through a direct or a representative system of government. In the process of developing and evaluating policy, it is important to discern whether all who
would like to contribute to the discussion have an opportunity to do so, even though expressing a concern does not mean that it will necessarily be addressed in the final policy.
Identifying and promoting the fundamental requirements for health in a community are of primary concern to public health.
The way in which a society is structured is reflected in the health of a community. The primary concern of public health is with these underlying structural aspects. While some important public health programs are curative in nature, the field as a whole must never lose sight of underlying causes and prevention. Because fundamental social structures affect many aspects of health, addressing the fundamental causes rather than more proximal causes is more truly preventive.
Knowledge is important and powerful.
We are to seek to improve our understanding of health and the means of protecting it through research and the accumulation of knowledge. Once obtained, there is a moral obligation in some instances to share what is known. For example, active and informed participation in policy-making processes requires access to relevant information. In other instances, such as information provided in confidence, there is an obligation to protect information.
Science is the basis for much of our public health knowledge.
The scientific method provides a relatively objective means of identifying the factors necessary for health in a population, and for evaluating policies and programs to protect and promote health. The full range of scientific
tools, including both quantitative and qualitative methods, and collaboration among the sciences is needed.
People are responsible to act on the basis of what they know
. Knowledge is not morally neutral and often demands action. Moreover, information is not to be gathered for idle interest. Public health should seek to translate available information into timely action. Often, the action required is research to fill in the gaps of what we don’t know.
Action is not based on information alone.
In many instances, action is required in the absence of all the information one would like. In other instances, policies are demanded by the fundamental value and dignity of each human being, even if implementing them is not calculated to be optimally efficient or cost-beneficial. In both of these situations, values inform the application of information or the action in the absence of information.
Bases for Action
Values and beliefs underlying the code
Values and beliefs underlying the code
Values and beliefs underlying the code
1. Public health should address principally the fundamental causes of disease and requirements for health, aiming to prevent adverse health outcomes.
2. Public health should achieve community health in a way that respects the rights of individuals in
3. Public health policies, programs, and priorities should be developed and evaluated through
processes that ensure an opportunity for input from community members.
4. Public health should advocate and work for the empowerment of disenfranchised community members,
aiming to ensure that the basic resources and conditions necessary for health are accessible to all.
5. Public health should seek the information needed to implement effective policies and programs
that protect and promote health.
6. Public health institutions should provide communities with the information they have that is
needed for decisions on policies or programs and should obtain the community’s consent for
7. Public health institutions should act in a timely manner on the information they have within the
resources and the mandate given to them by the public.
8. Public health programs and policies should incorporate a variety of approaches that anticipate
and respect diverse values, beliefs, and cultures in the community.
9. Public health programs and policies should be implemented in a manner that most enhances the physical and social environment.
10. Public health institutions should protect the confidentiality of information that can bring harm
to an individual or community if made public. Exceptions must be justified on the basis of the
high likelihood of significant harm to the individual or others.
11. Public health institutions should ensure the professional competence of their employees.
12. Public health institutions and their employees should engage in collaborations and affiliations in ways that build the public’s trust and the institution’s effectiveness.
Principles of the Ethical Practice of Public Health
Public health law
Public health law differs from ethics in that it is concerned with a body of rules of action prescribed by controlling authority and having binding legal force. Law is found in constitutions, statutes, regulations, and court cases, which interpret the constitution, statutes and regulations (and may set binding precedence).
Law is a tool in public health work which is used to influence norms for healthy behavior, identify and respond to health threats, and set and enforce health and safety standards. The most important social debates about public health take place in legal arenas such as legislatures, courts, and administrative agencies.
Law can be an effective tool to achieve the goal of improved health for the population. Statutes, regulations, and litigation, like other public health prevention strategies, intervene at a variety of levels, each designed to secure safer and healthier populations.
Government intervention is aimed at...
Individual behavior though education
For instance health education campaigns
Incentives or deterrence
For instance taxing and spending powers (incentives) or civil and criminal penalties for risky behaviors (deterrence)
Alteration of the informational, physical, or business environment.
For instance advertising restraints (informational); city planning and housing codes (physical); and inspections and licenses (business)
Public health is concerned with the health of the community as a whole and focuses on entire populations rather than on individuals.
Excerpt from: Mariner, W.K., Annas, G.J., & Glantz, L.H. (2005). Jacobsen v Massachusetts: It’s not your great-great-grandfather’s public health law. American Journal of Public Health, Vol 95, No. 4 pp. 581 – 590.
One hundred years after Jacobson, neither public health nor constitutional law is the same. Programs essential to today’s public health, such as those that regulate hazardous industries and products and that provide medical care, which would have been struck down in 1905, are routinely upheld today because they serve a legitimate public purpose and do not interfere with personal liberty. In contrast, deprivations of liberty that might have been upheld in 1905 would be struck down today. Public health now has better tools at its disposal: better science, engineering, drugs and vaccines, information, and communication mechanisms for educating the public. The history of US Supreme Court decisions about states’ power to restrict personal liberty shows the different ways in which states’ power can be characterized. At bottom, however, all doctrinal interpretations begin with 1 of 2 presumptions: (1) the state has complete power to do anything that is not expressly prohibited by the federal or its own state constitution, or (2) the state has only those powers granted to it by the people or that constitute an essential aspect of sovereignty for which governments are formed.
At a time when terrorism threatens the entire world, people may be easily convinced that their security depends upon giving up their liberty. People also may believe laws that restrict personal freedom will not apply to them. History supports the view that coercive laws have largely targeted disadvantaged minorities. Quarantine laws were most often directed at disfavored immigrant groups. During the 19th and early-20th century, people who were poor, nonwhite, or recent immigrants were widely believed to live in filth, intoxication, violence, and debauchery or were often blamed for harboring and spreading disease. Such attitudes may have surfaced when the Boston Board of Health sent police officers to inoculate “tramps” against smallpox. Police reportedly held some men down and beat others to accomplish their task. Although we may believe we are more enlightened today, similarly disfavored groups are targets of antiterrorism laws.
The Bill of Rights was designed to protect individuals against abuses by the state, even when the abuses have the support of the majority. This is why constitutional protection of liberty remains so important. One practical reason for protecting constitutional rights is that it encourages social solidarity. People are more likely to trust officials who protect their personal liberty. Without trust, public officials will not be able to persuade the public to take even the most reasonable precautions during an emergency, which will make a bad situation even worse. The public will support reasonable public health interventions if they trust public health officials to make sensible recommendations that are based on science and where the public is treated as part of the solution instead of the problem. Public health programs that are based on force are a relic of the 19th century; 21st-century public health depends on good science, good communication, and trust in public health officials to tell the truth. In each of these spheres, constitutional rights are the ally rather than the enemy of public health. Preserving the public’s health in the 21st century requires preserving respect for personal liberty.
197 U.S. 11 (1905), was a case in which the Supreme Court of the United States upheld the authority of states to pass compulsory vaccination laws. The Court’s decision articulated the view that the freedom of the individual must sometimes be subordinated to the common welfare, and is subject to the police power of the state.
A Lesson for Modern Public Health
Public health authorities have broad authority that grants power to institute a wide variety of measures to protect he public’s health and safety. With this power comes the responsibility to use that authority in a legal and ethical way.
Ethical choices are made in public health agencies every day. For the most part these choices are not visible to the public nor of particular concern, but in a crisis ethical choices are very visible and often at the center of controversy, concern, and high outrage like this one...
Public health laws under what is known as “police power,” is a broad concept that encompasses the functions historically undertaken by governments in regulating society.
The term “police power” is not mentioned in the Constitution of the United States. Rather, police power is inferred from the powers traditionally possessed by governments and exercised to protect the health, safety, welfare, and general well-being of the citizenry.
Police power has been used to uphold a wide variety of actions by the states, many quite broad in their reach and impact. Generally, such laws will be upheld if it can be shown that the laws are reasonable attempts to protect and promote the public’s health, safety, and general welfare and that the laws are not arbitrary or capricious attempts to accomplish such an end.
On the state level, all governmental authority (including expansive police power) resides with the state governments. The state governments, in turn, can and do authorize local governmental entities to exercise governmental authority on the local level. The establishment of local boards of health are authorized by state laws, which establish guidelines for their operation.
Public health functions may be divided among a number of governmental departments—health, environment, registration, etc. Often local boards of education have principal responsibility for conducting school health programs, and state departments of education have primary regulatory responsibility for school health services.
Principles of Public Health
Bloustein School of Planning and Public Policy
Rutgers, The State University
Planners have not generally communicated the ethical underpinnings of their choices in a clear manner. But ethical issues have surfaced in public debates, often in the news media. [In a pandemic] should people purchase their own stockpiles of antiviral drugs such as Tamiflu, or should they accept governments’ decisions on how to allocate such medications? When medications are distributed, should children come before or after health care and emergency services workers, or decision makers such politicians?
Government and health care leaders need to make the values behind their decisions public. They should discuss the values with people who could be affected, ranging from health care workers, who will find themselves on the front lines, to government officials, who are making decisions about the allocation of limited resources, to the public at large, because people will be affected in many ways. They need to do this in advance of a health crisis, not when people are lining up at emergency ward doors.
Openly discussing the choices and confirming that they are based on ethical values that are shared by members of a society brings important benefits. If ethics are clearly built into pandemic plans in an open and transparent manner, and with buy-in from multiple sectors of society, the plans carry greater trust, authority and legitimacy. Advance discussions of such issues can help to address fears of the unknown. People will be more likely to cooperate, and accept difficult decisions made by their leaders for the common good.
Excerpted from: Joint Centre for Bioethics, University of Toronto, Pandemic Influenza Working Group (2005).
Stand on guard for thee: Ethical considerations in preparedness planning for pandemic influenza.
Public health plans and decisions should clearly communicate the ethical underpinnings of choices that are made
: Proportionality requires that restrictions to individual liberty and measures taken to protect the public form harm should not exceed what is necessary to address the actual level of risk to the community (or the actual needs of the community).
: Individuals have the right to privacy in health care. In a public health crisis it may be necessary to override this right to protect the public from serious harm.
Duty to Provide Care
: Inherent to all codes of ethics for health care professionals is the duty to provide care and to respond to suffering. Health care providers have to weigh demands of their roles against competing obligations to their own health, and to family and friends.
: Requires that society support those who face a disproportionate burden in protecting the public good and take measures to minimize that burden.
: Difficult decisions will need to be made about which health services to maintain and which to curtail.
: Decision makers will be confronted with the challenge of maintaining stakeholder trust implementing various control measures during an evolving health crisis. Trust is enhanced by upholding values such as transparency and honesty.
: A health crisis such as a pandemic can challenge ideas of sovereignty, security or territory. Collaborative approaches that set aside traditional values of self-interest is required among response partners, health care institutions, institutions, cities, counties, states & nations.
: Those entrusted with governance roles should be guided by the concept of stewardship. Inherent in the concept is trust, ethical behavior, and good decision-making.
Issues to consider in ethical decision making
- Joint Centre for Bioethics, University of Toronto
When faced with an ethical dilemma what choices do you have?
If you are interested in learning more about public health ethics, watch the PBS, NOVA documentary,
The Most Dangerous Woman in America
. The case of "Typhoid Mary" is well known to students of public health and is an old but still relevant case.
Principles and values that help guide actions designed to promote health and prevent injury and disease in the population
Public Health Leadership Society, Centers for Disease Control and Prevention, & American Public Health Association. Principles of the Ethical Practice of Public Health, 2002.
Identify the ethical problem(s) germane to the decision
Assess the factual information available to the decision-maker(s)
Identify the “stakeholders” in the decision
Identify the values at stake in the decision
Identify the options available to the
Consider the process for making the decision and the values that pertain to the process
protecting another from harm
respect for other people
the growth of scientific knowledge
Lundgrin and McMakin
When faced with an ethical dilemma, what choices do you have?
Ethical decision making
CBS Evening News. (2014)
Christie defends Ebola quarantine.
Joint Centre for Bioethics, University of Toronto
Did Governor Christie's quarantine order for medical personnel at Newark Airport meet these criteria? What do you think?
WCBV Channel 5 Boston. (2014)
Doc who survived Ebola speechless over treatment of quarantined nurse.
Chris Christie Stands By Mandatory Ebola Quarantine Despite Criticism
As you scroll through the presentation, read the embedded text and view the videos. Some frames may have a voice over that will play automatically. The information contained in the frames is pretty self-explanatory, but if you have any questions email me. Be sure to view the second presentation on the Week 5 page on public health surveillance.
Jacobsen was levied a $5 fine for refusing to be vaccinated against smallpox during an outbreak. He refused to pay.
In recent years, public health and the law have frequently interacted. A variety of issues have led to the government stepping in to create legislation that affects the individual in order to protect the general public. These actions are grounded in the 1905 Supreme Court case Jacobson v. Massachusetts. Jacobson set the stage for almost all public health law to follow. However, the case has had more than just a legal impact. In fact, Jacobson has made its mark on both societal policies and trends in healthcare and medicine. The case set a precedent for the valuing of public health over individual liberties when the two come into conflict... When it comes to most public health actions, the government will act to provide the greatest amount of good for the greatest number of people.
Police power describes the basic right of governments to make laws and regulations for the benefit of their communities. Under the system of government in the United States, only states have the right to make laws based on their police power. The lawmaking power of the federal government is limited to the specific grants of power found in the Constitution.
- West's Encyclopedia of American Law
What is "police power"?
This venn diagram illustrates the inter-relatedness of professional, applied and advocacy ethics in public health.
Decision making is central to what public health officials and practitioners do. Big decisions (like making policy that will become law) and every day decisions (like conducting an outbreak investigation) are made within an ethical framework. How well this is done depends on a lot of variables which we will look at in this presentation.
Public health decisions are made within a larger environment that encompasses biology, medicine, and health care.
Another venn diagram that shows that the field of bioethics and public health ethics are not "stand alone", rather they are inter-related and have points of intersection. The little guy is there to remind you that in clinical practice the emphasis is on the individual and in public health practice the focus is on a population. But that doesn't mean that in public health we aren't concerned about the welfare of the individual or that a clinical practitioner isn't concerned with the public's health - that would be unethical!
What happens when the needs of the individual and the needs of the community are not perceived as the same? Can you think of other examples of this conflict?
If public health officials are not trusted by the public, it is doubtful that the interventions they seek to implement - from getting people evacuate a city because of an impending hurricane to eating healthful food - will succeed!
Keeping populations of a community free from viral disease rests in part on the success of herd immunity. Herd immunity rests on the principle of safety in numbers; if more people are immune to a certain virus, either through vaccination or through already having the disease, then more people in the population, even if they themselves aren't immune, are protected from the disease (Edmonds, M).
For approaches such as herd immunity to work, the basic bargain of civilization upheld by Jacobsen must be struck. “The public will support reasonable public health interventions if they trust public health officials to make sensible recommendations that are based on science and where the public is treated as part of the solution instead of the problem” (Mariner).
Here is an example... This is Deershead, a facility in Maryland where people with active tuberculosis are kept in isolation while they are being treated until no longer infectious. People found to have active TB almost always voluntarily agree to isolate in their own homes while they begin daily treatment for TB and until they are no infective - usually a couple of weeks. In rare cases, infectious individuals do not cooperate in their treatment or refuse to isolate themselves. In these cases, pubic health officials can invoke police powers to impel treatment and isolation. I made the decision once (in consultation with the head of TB control at the State, the county health officer, and the State Police) to confine a person with active TB to Deershead. It was a decision that was made only after all options had been exhausted and it was not made lightly!
Not all decisions are as dramatic as this, some more routine examples are the quarantine of a pet who has bitten someone, closing a restaurant that isn't compliant with food safety regulations, or excluding a child from attending day care until she is free of head lice.
How not to gain the trust of the public!
This is a document that I kept on the wall of my office as my staff of nurses, an epidemiologist, and sanitarians made decisions that had an impact on the residents of our community. We referred to it often!
The fictionalized character Miss Evers is based in part on Nurse Eunice Rivers, who served throughout most of the Tuskegee study. In her we see the deep conflicts of a caring nurse-who was indispensable to the research project because of the trust she engendered in the research subjects-between her loyalty to the authority of the physicians she worked with and her own growing realization that she had become a principal agent in moral outrage. She embodies the conflicts many of us must feel when what is required of us as human beings conflicts with what is required of us by our roles. Such conflicts are the stuff of tragedy, from Abraham to Nixon, from Antigone to Edelman. Many times we try to make contradictions disappear. We deny the conflict or take the easy way out.
Repression of our moral contradictions sets us on the road to self deception. The power of this story is its sensitive exploration of the interplay of deception and self deception, of science degenerating into exploitation, of the separation of the men in the study from being viewed as human brothers that allowed researchers to dispassionately document the ravaging of their bodies. Miss Evers never fully repressed these contradictions. To watch her suffer these conflicts is to feel human tragedy. We hope this film, like all great art, can inspire a large audience with its lessons.
- James Fowler and Steve Olson, Center for Ethics in Public Policy and the Professions.
If you are interested in the Tuskegee Study, you can watch the movie "Miss Evers' Boys" online (search on YouTube for a few viewing options). Below is an except from an article written about the movie by public health ethicists.
Tuskegee Human Rights Center. Tuskegee Syphilis Study apology from President Bill Clinton. (3:57)
The Tuskegee Study Begins
In 1932, the U.S. Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called the "Tuskegee Study of Untreated Syphilis in the Negro Male."
The study initially involved 600 black men – 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients' informed consent. Researchers told the men they were being treated for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.
What Went Wrong?
In July 1972, an Associated Press story about the Tuskegee Study caused a public outcry that led the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review the study. The panel had nine members from the fields of medicine, law, religion, labor, education, health administration, and public affairs.
The panel found that the men had agreed freely to be examined and treated. However, there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent.
The men were never given adequate treatment for their disease. Even when penicillin became the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. The advisory panel found nothing to show that subjects were ever given the choice of quitting the study, even when this new, highly effective treatment became widely used.
The Study Ends and Reparation Begins
The advisory panel concluded that the Tuskegee Study was "ethically unjustified"--the knowledge gained was sparse when compared with the risks the study posed for its subjects. In October 1972, the panel advised stopping the study at once. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the Tuskegee Study.
In the summer of 1973, a class-action lawsuit was filed on behalf of the study participants and their families. In 1974, a $10 million out-of-court settlement was reached. As part of the settlement, the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, wives, widows and offspring were added to the program. In 1995, the program was expanded to include health as well as medical benefits.
If you already viewed the Week 5 presentation on disease surveillance, you will be familiar with the Framingham corhort study. The Tuskeegee study (also a cohort study) is a tragic and shocking chapter in public health history, but one worthy of study to insure that injustice and harm is never perpetuated in the name of public health again.
The Department's Institutional Review Board (IRB) assures the protection and safety, rights and welfare of human subjects in research.
The IRB approves human subjects research projects that adhere to the ethical principles set forth in The Belmont Report (Respect for Persons, Beneficence and Justice) and the Federal regulations for the protection of human subjects, including Title 45, Part 46.
New Jersey Department of Health
1978 - National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research - The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence ("do no harm", and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects.
1947 - The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.
1964 - World Health Organization - The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document of human research ethics. 1975 revision clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society" as well as establishing the system of IRB.
- NJ DoH
National Research Act - 1974
Mandates the establishment of Institutional Review Boards (IRB) to review all federally funded grants involving human subjects.
U.S. Department of Health and Human Services issues revised regulations on human subjects research referred to as Common Rule (Title 45 Code of Federal Regulations). Many institutions not legally obligated to abide by the Common Rule have adopted it and many states have similar regulations. The Common Rule defines eight elements needed for a person to give "informed consent" to participate in a research project.
1. A statement that the study involves research,
and description of that research and its purposes
2. A description of the reasonably foreseeable risks
3. A description of the reasonably expected benefits
4. A Disclosure of appropriate alternatives
5. A statement about maintenance of confidentiality
6. An explanation of possible compensation in case of injury, if the study involves more than minimal risks
7. Information about how subjects can have questions answered
8. A statement that participation is voluntary
1. Informed consent
2. Standard of care
3. Ethical review
4. A plan for after research ends
Remaining ethical in the search for a cure
TEDTalk. Boghuma Kabisen Titanji: Ethical
riddles in HIV research. (11:11)
Today, it is shocking to think that ethical standards for research were absent in the latter half of the 20th century. The aftermath of the Tuskegee Study spurred the creation and passage of the National Research Act of 1974.
A super-brief timeline of the evolution of ethical standards
Research you do at Rutgers must be in compliance with New Jersey's rules. If you have been a research assistant you may already be familiar with IRB (Institutional Review Boards).