health research ethics ppt

Understand the principles of Human Research Ethics

Are you supporting or planning to engage in research with or about people, their data or their tissue? A new, self-paced learning module now available on Canvas entitled Human Research Ethics introduces its values, principles and review.

The module provides information to help you design a human research project and understand how ethics reviewers will consider your design against the guidance provided in the National Statement on Ethical Conduct in Human Research .

Based on, and directly cross referencing with the National Statement, the module outlines why research ethics review was introduced internationally. It introduces the key agencies and documents associated with Australian ethics review and points out important changes in 2023 National Statement. These include a refined risk matrix approach and the requirements of granting an exemption from ethics review.

Merrilee Kessler, UTS Research Ethics Coordinator said that UTS commissioned this module for its research community.

“We wanted to provide a course that introduced the key research ethics concepts such as risk and benefit, consent, recruitment and data management, in a way that helps researchers understand the language and intent of ethics review,” she said.

The module highlights the kinds of responses needed in an ethics application to show that the research design meets the expectations of the National Statement. It looks at current issues like AI, social media in research and Big Data.

“It also includes research that UTS doesn’t come across as often, but which provides great scope for ethical investigation, such as Genomic research and Animal-to-human xenotransplantation,” Merrilee explained.

We wanted to provide a course that introduced the key research ethics concepts such as risk and benefit, consent, recruitment and data management

Keith Heggart, UTS researcher and ethics reviewer, was one of the first to complete the module.

“I think it’s important for early career researchers to understand that going through the ethics process is not just a matter of ticking the right boxes and filling in the right forms. Instead, it’s a thoughtful, nuanced engagement with ideas like justice, beneficence and risk,” he said.

“Done well, careful completion of the ethics approval process improves research projects. This course does a great job of carefully explaining this point, and as such, I recommend it for all early career researchers - and experienced ones too!”

Done well, careful completion of the ethics approval process improves research projects.

Contributing to research excellence

Importantly, the Human Research Ethics module covers key aspects of the UTS Research Outcomes Capability Framework | RES Hub (uts.edu.au) including those relating to:

• Research life cycle: Best practice in research project management from research ethics and integrity, policy and procedures, data management policy and systems to IP management and security.
• Research leadership: Confidence to champion research integrity and best practice in research project management, mentor successfully and deliver ethical and robust research with integrity.
• Creativity and innovation: Knowledge of ‘human-centred’ research methods and practices. 
• Indigenous led knowledges and research: Knowledge and understanding of Indigenous Research Ethics (e.g. AIATSIS, NHMRC, community protocols) and the ability to ensure that research processes and outputs will not harm Indigenous peoples and communities.

“We also look at the relevant UTS policies, procedures and systems,” added Merrilee.

“At the end of the course, participants will have the ability to identify and manage risk and appropriately manage data – including by planning for re-use and reproducibility, archiving and sharing with appropriate audiences.”

About the Human Research Ethics Module

Human Research Ethics  takes approximately two hours to complete and can be accessed as many times as needed once an account has been opened.

A Certificate of Completion is available for download.

Access the training at https://canvas.uts.edu.au/enroll/GEKRK8

Find ethics training and support

• Visit the Ethics Sharepoint site - Research Ethics and Integrity - Home (sharepoint.com)
• Make an appointment to attend clinics for Animal Ethics, General Research Ethics or Health Related Research  - Ethics clinics (sharepoint.com)
• Register for Good Clinical Practice (GCP) training-   GCP training page

Need more information? Get in touch with the Research Ethics team by email [email protected]

RES Hub acknowledges and pays respect to the Gadigal people of the Eora Nation, the Boorooberongal people of the Dharug Nation, the Bidiagal people and the Gamaygal people, upon whose ancestral lands where UTS now stands.

We pay respect to their Elders; past, present, emerging and future as the traditional custodians of Country and knowledge for this land. We recognise their continued connection to the land and waters and the continuation of their cultural, spiritual, and educational practices. We extend this respect to all Aboriginal and/or Torres Strait Islander peoples who visit RES Hub.

As a place for the UTS community to connect and collaborate, RES Hub acknowledges the long-standing traditional practices of these communities in gathering to share experience, knowledge, and history. RES Hub acknowledges that sovereignty was never ceded. This is and always will be Aboriginal Land. 

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Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

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The new WHO publication “Standards and operational guidance for ethics review of health-related research with human participants”, is a compilation of 10 standards that are applicable to the ethics review of health related research with human participants. This document is intended to provide guidance on the research ethics review process, not to take a substantive position on how particular ethical dilemmas in health-related research should be resolved. It is designed to serve as a basis upon which Research Ethics Committees (RECs) can develop their own specific practices and written procedures, and benchmark their achievements.

The term “standards” is used to delineate general principles and norms that all research ethics systems are expected to follow. This publication highlights the importance of a systems approach to research ethics, and includes and delineates the role of national governments and relevant legal and regulatory authorities.

• Collapse All
• Acknowledgements
• Standard 1 Responsibility for establishing the research ethics review system
• Standard 2 Composition of research ethics committees
• Standard 3 Research ethics committee resources
• Standard 4 Independence of research ethics committees
• Standard 5 Training the research ethics committee
• Standard 6 Transparency, accountability, and quality of the research ethics committee
• Standard 7 Ethical basis for decision-making in research ethics committees
• Standard 8 Decision-making procedures for research ethics committees
• Standard 9 Written policies and procedures
• Standard 10 Researchers' responsibilities
• Annex 1 Guidelines and codes of best practice and statutes and regulations
• Annex 2 Guidance for developing terms of reference for the Secretariat of the research ethics committee
• Annex 3 Guidance for developing written procedures for the research ethics committee

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

All rights reserved. Publications of the World Health Organization are available on the WHO web site ( www.who.int ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob ).

Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site ( http://www.who.int/about/licensing/copyright_form/en/index.html ).

• Cite this Page Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.
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National Institute of Environmental Health Sciences

Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

December 23, 2020

The ideas and opinions expressed in this essay are the author’s own and do not necessarily represent those of the NIH, NIEHS, or US government.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

Promoting Ethical Conduct in Science

Do U.S. research institutions meet or exceed federal mandates for instruction in responsible conduct of research? A national survey

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Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

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Chapter 4: Research Ethics

2014, Doing Research in the Real World, 3rd edn

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ABSTRACT This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.

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Global health ethics

Ethical questions related to health, health care, and public health cover topics as diverse as moral issues around reproduction, state obligations in the provision of health care services, and appropriate measures to control infectious disease. Scholars and health care professionals have debated ethical questions related to health and health care since the earliest days of medicine. Recent formal efforts to articulate international standards of ethics applicable to health and health care can be traced to the Nuremberg trials of 1947, during which the horrors of Nazi medical experiments came to light.

The principles that emerged from those trials, known as the Nuremberg Code, are broadly applicable to many types of health-related research involving human participants, including clinical trials. The growing breadth and complexity of contemporary health challenges have produced a range of difficult questions that cannot always be adequately addressed by relying exclusively on existing policies, guidelines or codes of conduct. Debates over access to new and expensive pharmaceuticals and medical technologies, as well as increasing awareness of the gross health disparities that exist both within and between countries, have called attention to the need for an ethics of health policy and practice.

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants.

The WHO Manual (Section XV.2) defines research with human subjects as 'any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings:

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INTRODUCTION TO MEDICAL ETHICS

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Ethics in Research

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Ethics in Research. Chapter 2.1. What are ethics?. Ethics – the standards set for proper and responsible behavior. Ethical dilemmas . situations in which there is a choice to be made between two options, neither of which resolves the situation in an ethically acceptable fashion.

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Ethics in Research Chapter 2.1

What are ethics? • Ethics – the standards set for proper and responsible behavior

Ethical dilemmas • situations in which there is a choice to be made between two options, neither of which resolves the situation in an ethically acceptable fashion http://examples.yourdictionary.com/ethical-dilemma-examples.html

Personal Friendships Michael had several friends including Roger and Daniel. Roger has recently met and started dating a wonderful lady named Phyllis. He is convinced this is a long term relationship. Unknown to Roger, Michael observed them at a restaurant several days ago and realized Phyllis is the wife of his other friend Daniel. Michael is deciding whether to tell Roger that Phyllis is married when he receives a call from Daniel. Daniel suspects his wife is having an affair and since they and Michael share many friends and contacts, he asks if Michael has heard anything regarding an affair. http://examples.yourdictionary.com/ethical-dilemma-examples.html

Who lives? • A pregnant woman leading a group of people out of a cave on a coast is stuck in the mouth of that cave. In a short time high tide will be upon them, and unless she is unstuck, they will all be drowned except the woman, whose head is out of the cave. Fortunately, (or unfortunately,) someone has with him a stick of dynamite. There seems no way to get the pregnant woman loose without using the dynamite which will inevitably kill her; but if they do not use it everyone will drown. What should they do? http://examples.yourdictionary.com/ethical-dilemma-examples.html

Keep your word or not? The mood at Baileyville High School is tense with anticipation. For the first time in many, many years, the varsity basketball team has made it to the state semifinals. The community is excited too, and everyone is making plans to attend the big event next Saturday night. Jeff, the varsity coach, has been waiting for years to field such a team. Speed, teamwork, balance: they've got it all. Only one more week to practice, he tells his team, and not a rule can be broken. Everyone must be at practice each night at the regularly scheduled time: No Exceptions. Brad and Mike are two of the team's starters.  From their perspective, they're indispensable to the team, the guys who will bring victory to Baileyville. They decide—why, no one will ever know—to show up an hour late to the next day's practice. Jeff is furious. They have deliberately disobeyed his orders. The rule says they should be suspended for one full week. If he follows the rule, Brad and Mike will not play in the semifinals. But the whole team is depending on them.  What should he do? http://examples.yourdictionary.com/ethical-dilemma-examples.html

Ethics and Psychology • What ethical dilemmas might come up in your studies?

Ethical Guidelines • What ethical guidelines/rules should we follow?

APA Ethical Guidelines • Minimize misleading results • Protect the health, dignity & privacy of people involved • Obey all laws • Create rights and responsibilities for all involved before starting a study • Get signed permission • Do not lie or give false information to participants about the study • Use data and results appropriately

Ethics & Animal Rights • Do animals have rights? • Is it ok to hurt an animal if it helps save lives?

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• Preferences

ETHICS IN GLOBAL HEALTH: BEYOND HIPPOCRATES - PowerPoint PPT Presentation

ETHICS IN GLOBAL HEALTH: BEYOND HIPPOCRATES

Ethics in global health: beyond hippocrates scott loeliger, md, ms mark stinson fellowship in global and underserved health contra costa family medicine residency – powerpoint ppt presentation.

• Review the historical context of ethics within medical training and practice.
• Understand the place of ethics within the new medical professionalism.
• Incorporate the concepts of ethical behavior and practice into service learning activities.
• Encourage open discussion about current controversies and new generation focus on global health work.
• Hippocratic Oath
• (4th Century BC)
• Universal Declaration of Human Rights (1948)
• The New Hippocratic Oath (1966)
• The Declaration of Alma Ata (1978)
• Declaration of Helsinki (1964-2004)
• Millennium Development Goals (2000)
• Primum non Nocerum to Primum non Tacere.
• Physician Charter on Medical Professionalism.
• Healing in the context of Social Justice.
• Residents with Skills Helpful or Dangerous?
• The Physician Charter
• Physician Charter Construct for Medical Professionalism
• Formal learning and didactics.
• Pre-experience preparation.
• Consideration of ethics in underserved local communities.
• Understanding complexities of global realities, institutions, processes and programs.
• Self- study and self-reflection.
• Short term clinical work combined with tourism.
• Attachment to clinical research project.
• Longer term work with NGOs or Universities.
• Advisor/Teacher or Medical Corps?
• All done in the name of Hippocrates is not right.
• Physician centered paradigm can distort true health improvements.
• Resource poor areas require careful attention to appropriate strategies.
• Attention to the Immediate versus the Sustainable.
• We are going there, whos coming here?
• Raised expectations without means to correct health manpower deficiencies.
• True professional exchanges, joining the growing global debate (Global Health Workforce Alliance).
• Translating Ours to Theirs.
• While working in health care, how to attend to social injustice and underlying factors of poor health.
• Training leaders, followers, co-conspirators or colleagues?
• Respect for emerging literature and research from abroad.
• Recently developed (2007-08).
• Included input from APHA, Partners in Health, Physicians for Human Rights, Save the Children, AMREF, GHETS, WHO, World Bank and others.
• Most recent consultation in Kampala during March global forum on human resourses for health.
• Next consultation at APHA meeting in October, 2008
• I. NGOs will engage in hiring practices that ensure long-term health system sustainability.
• II. NGOs will enact employee compensation practices that strengthen the public sector.
• III. NGOs will pledge to create and maintain human resources training and support systems that are good for the countries where they work.
• IV. NGOs will minimize the NGO management burden for ministries.
• V. NGOs will support Ministries of Health as they engage with communities.
• VI. NGOs will advocate for policies that promote and support the public sector.
• Global health research may have some ethical flaws.
• Interventions determined by narrow research goals may not be sustainable.
• Article 25 of Universal Declaration of Human Rights.
• WMA and Declaration of Helsinki.
• Think Global, Consider Local.
• Incorporate the Experience into Your Future Practice
• Work in Your Milieu to Integrate Service Learning into the Medical School and Residency Experience.
• In Your Medical Bag
• Stethoscope Check Ophthalmoscope-Check Sansome Guide Check Language Dictionary Check Ethical Guidelines-Check?
• 1 Filling In A Little Knowledge is a
• 2 Vertical Projects We Only Do
• 3 Ignoring Bureaucratic Barriers
• 4 NGO/Institutional Short Time Work
• Markle, W, et al. editors. Understanding Global Health. McGrawHill Medical, 2007, 362pp.
• Evert, J., et al. Developing Residency Training in Global Health A Guidebook. San Francisco Global Health Education Consortium, 2008. 119pp.
• ONeil, E. Awakening Hippocrates A primer on health, poverty and global service. AMA, 2006. 502 pp.

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