Appendix E: Health Sciences Module
Health Sciences
Introduction to Health Sciences
Welcome to the Health Sciences portion of the Research Integrity in International Collaborative
Contexts course. Please read this brief background as to the importance of this topic before exploring
the four areas of content.
Collaborative Research
Conflicts of Interest
Publication Practices and Responsible Authorship
Data Management: Access, Sharing, and Exchange
Additional Resources
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Appendix E: Health Sciences Module
Introduction to Health Sciences
Throughout the world, laws, guidelines, and principles have been established to protect humans and
animals from harm in research. These guidelines and laws are an attempt at a universal set of ethical
principles, but cultural and national differences strongly impact their interpretation and
implementation. The definition of harm is not universal, which can create conflicts in the interpretation
of guidelines cross-culturally. Multiple issues in international research ethics concern beneficence, nonmaleficence, social justice, and informed consent. Social and cultural factors often affect how
researchers view ethical conduct, values, and behaviors. This module provides students with an indepth overview of ethical principles and standards as they apply to international collaborative research
in the health sciences.
Health sciences are a set of basic and applied sciences whose focus is to develop bodies of knowledge,
interventions, and technologies for use in public health and healthcare settings. There are codes,
guidelines, and laws that govern conduct in these disciplines. Codes of conduct are prescribed, while
ethical codes are aspirational. Codes of conduct set the standard for how specific behaviors can and
cannot be achieved in particular situations. Ethical codes stipulate the standards by which we should be
held accountable in our professions. Regulatory bodies have their own codes of ethics, which may come
into conflict with our individual codes of conduct when working as collaborative researchers.
Ethics is th e concept of balancing the benefits and risks of choices and decisions. The underlying
heritage of ethics is present in all cultures, religions, and in ancient writings from around the world
(Macer, 1994). Research integrity includes (National Institutes of Health, 2013):
•
the use of honest and verifiable methods in proposing, performing, and evaluating research
•
reporting research results with particular attention to adherence to rules, regulation s, and
guidelines, and
•
following commonly accepted professional codes or norms
Ethical co nsiderations in international research contexts are vast and complex, especially in the health
sciences. First, health sciences research is multi-disciplinary and interdisciplinary, encompassing
different disciplines, countries, cultures, and social and political identities and beliefs. Second, there are
various stakeholders involved in the research, including governmental agencies, healthcare providers,
corporations, administrative personnel, and the variou s communities of study. Scientific research
should always encompass the values of honesty, accuracy, efficiency, and objectivity. Research ers
working in international contexts and with international collaborators must understand the different
research, cultural, and social norms of that country, as well as the differences in guidelines, regulations,
and policies.
This module focuses on national and international guidelines and the complex issues of conducting
research in cross-cultural and international contexts. In this module, you will examine
1.
power differences that occur across gender, rank, class, institutional stru ctures, and
international cultures and government structures
2.
co llabo rative research and how it changes in international contexts
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Appendix E: Health Sciences Module
3. how conflicts of interest can arise in research and suggestions for avoiding or resolving the
conflicts
4. publication practices and responsible authorship, and
5. data management, including the access, sharing, and exchange of information
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Appendix E: Health Sciences Module
Collaborative Research
Goals
When you have finished reading the information in this section, you should be able to :
•
•
Define ethics and be familiar with ethical guidelines
Understand recent trends in international collaboration in the health sciences
•
•
Describe some of the factors that have contributed to those trends
Understand the challenges of international collaboration in terms of rules and regulations
You will take a short quiz after completing the module to test your understanding of the content.
Collaborative Research in the Health Sciences
Collaborative research in the health sciences involves working with multiple researchers, healthcare
providers, patients, and research subjects to complete a research project. Research often crosses
physica l, social, and cultural boundaries, and researchers must be aware of these different contexts.
Understanding the cultural norms and practices of other researchers and participants will allow you to
conduct your research in a culturally sensitive manner to ensure a good working relationship with your
colleagues and research subject s.
History of Research Related Ethics
Research is a historically recent cu ltural activity, which begins with the development of " Positivist"
philosophy and the creation of the scientific method. A large portion of the scientific revolution of the
past couple of centuries was devoted to exploring the physical and biological world first, and then
exploring the social and cultural domains of human existence second. However, before the philosophy
of science and the idea of research existed, there were ethical guidelines t hat governed how human
beings were supposed to treat one another. There was also a longstanding history on the whole subject
of "eth ics" as an area of philosoph ical exploration and discussion. These two conditions, the moral
guidelines and th e philosophical principles of ethics, produced the basic concepts, values, and beliefs
that are the foundation for current research ethics guidelines.
One of the early foundations for human resea rch guidelines is embedded in the historical trend to codify
law, such as Hammurabi's first written legal principles that are the historic precedent for subsequent
written legal codes throughout the world (with the emphasis on the "rule of law") (Hammurabi, trans.,
1915). A second, very central foundation for resea rch ethics guidelines comes from religiou s sources.
One example is the religious prescriptions and principles contained in the 10 Commandments in JudeoChristian cultu res and other religiously based rules for understanding the difference between right and
wrong. The final foundation is the historical development of ethical principles rangin g from early Greek
philosophica l writings through the Bill of Rights in the United States Constitution and into the present
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day. These foundations are not the direct subject of this module, but they are important to
understanding the basic foundations for both the ethical principles for human research.
Ethical Principles
There are three critical principles that are the foundation for ethical treatment of people in human
research. The principles are:
1.
2.
3.
Respect for persons
Maximizing good for people and minimizing harm
Social justice for people participating in human research.
Researchers should approach every research project with respect for their collaborators and resea rch
participants in the areas of cultural, religious, social, and political identities and beliefs, especially when
working internationally or with vulnerable populations. If you understand that differences will arise and
communication is key to the success of the project, then you can conduct respectful and culturally
sensitive resea rch with your collaborators and participants.
Whenever conducting research, whether with human or non-human research subjects, researchers
must consider any possible ways that the research might cause harm to the subjects, including, but not
limited to, physical, material, and mental well-being. When working with vulnerable populations, it is
especially important to consider these factors. Health scientists should avoid causing direct and
immediate harm to their subjects but must also consider potential consequences and inadvertent
impacts of their work (American Association of Anthropology, 2014).
If you choose to link your research to the promotion of well-being, socia l crit ique or advocacy, you must
determine what is in the best interests of others or what kinds of efforts are appropriate to increase
well-being. These choices are often value- laden and should reflect sustained discussion you're your
collaborators to ensure that everyone's thoughts are considered (American Association of Anthropology,
2014).
Current Trends in Health Sciences Research
Research involving human subjects requires significa nt legal and ethical considerations. Researchers
failing to comply with regulations, guidelines, and laws are a current issue in health science research,
often leading to litigation. Researchers must be familiar with laws and guidelines related to human
subjects protection, medical privacy, and th e disclosure of medical records and research results
(Kulynych, 2002).
Failure to meet the guiding principles and laws related to human subjects' research is not only unethical,
but it could put your collaborators at risk. Compliance failures may damage the reputation of
researchers, their institutions, or the discipline itse lf. Research subjects suffering adverse effects,
allegedly as a consequence of ethica l and regulatory lapses on the part of researchers and institutions,
were cit ed in recent lawsuit s (Blum enstyk, 2002). These allegations could result in governmental
investigations, possibly resu lting in severe regulatory sa nctions or the researchers or institutions.
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When conducting research in the health sciences, consider these factors (Kulynych, 2002):
Federal regulations and some state laws require IRB approval and informed consent for all nonexempt human subjects research.
2. FDA regulations requiring an lnvestigational New Drug Application or lnvestigational Device
Exemption for safety and efficacy studies involving unapproved uses of drugs or medical
devices, and FDA regulations imposing certain obligations upon principal investigators in clinical
investigations (e.g., reporting requirements for adverse events).
3. Federal, state, and institutional requirements for the disclosure of investigators' financial
interests in human subjects research. These requirements may be embodied in state law,
federal regulation, or institutional policy.
4. The new federal medical privacy rule, which in April of 2003 required researchers using
1.
"identifiable" health information obtained in clinical settings to seek a very specific form of
written authorization from each patient, or alternatively, a waiver of authorization from an IRB
or "privacy board ."
Health Privacy Resources
•
Health Information Privacy (including HIPPA)
Human Subjects Compliance and Institutional Review Board
•
NAU Human Subjects Compliance and Institutional Review Board
•
Health and Human Services- Institutional Review Boards
Cross-Cultural and International Issues
The development of international, rather than national or regional, treaties and guidelines follows a very
similar path compared with the development of international organizations, such as the United Nations
(UN). The UN Universal Declaration of Human Rights is a critical document for guiding rules and treaties
about the application of ethical principles to all areas of human endeavor, including research (The
United Nations, 2011). As the capacity for intensive research developed internationally, there has been a
need to clarify, expand, and explain the specific ethical principles that govern research on human beings.
This part ofthe module provides an introduction to those principles and processes.
Research that focuses on cultural differences in human beliefs, behaviors, rules, and lifestyles presents a
number of significant challenges for an ethical research design. Anthropology generally follows the
concept of "cultural relativism," which places the strongest emphasis on the beliefs and consensual
ethical views of the people being studied, rather than those conducting the research. This approach
suggests that beliefs, values, and ethics are valid only in cultural context, rather than universal;
whatever people think is right, based on cultural consensus, is what is right. If infanticide is an
acceptable cultural practice, then behavior within a research context should be judged by that standard,
rather than by an externally imposed standard, based on a relativist point of view. However, beginning
with the UN Declaration of UNIVERSAL human rights (The United Nations, 2011), ethical guidelines and
human subjects' rules, regulations, and processes take a universalist, rather than relativist view.
Situational ethics are not favored, only the application of universal principles.
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Researchers must weigh competing ethical obligations to collaborators, participants, students,
professional colleagues, employers, and funders. Collaboration requires making difficult decisions
among competing ethical obligations with the obligations to your research participants (American
Anthropological Association, 2014). Guidelines of the collaborative research project must be defined
and understood by the various participants, including the scope of the project and the rights and
responsibilities of the researchers and participants.
Guidelines
Health science researchers must abide by certain principles and ethical codes. Principles, guidelines,
rules, and codes do not change when engaging in cross-cultural or international research, but
researchers should adhere to them in a culturally responsible and sensitive manner. Researchers
engaging in collaborative, international research will also need to review any principles, guidelines,
rules, and codes for the respective countries where they will conduct research. Health scientists should
always check with their international collaborators about any principles, rules, and guidelines for that
country.
Informed Consent
Researchers working with human subjects should obtain voluntary and informed consent of all research
participants. This process is usually done prior to commencing research and should be part of the
project design. This consent should involve "disclosing the research goals, methods, funding sources or
sponsors, expected outcomes, anticipated impacts of the research, and the rights and responsibilities of
research participants" (American Anthropological Association, 2014). Researchers should also discuss
possible impacts of participation and despite their best efforts, confidentiality may be compromised or
outcomes may differ from those expected. Although these expectations apply to data in all mediums,
research involving visual media should be carefully "used, referenced, and contextualized" (American
Anthropological Association, 2014), as anything electronically recorded can make people feel
marginalized or vulnerable. If the project or research changes in a way that will affect participants,
consent must be revisited and renegotiated, as the consent process, like the research process, is fluid,
dynamic, and ever-changing.
Ethical Codes and Principles of Responsibility
Consult your respective national organizations' ethical codes for guidelines and rules specific to your
discipline. Here a few examples of ethical codes and principles of responsibility for conducting research
in the health sciences:
National Codes of Ethics
•
•
•
•
•
•
•
American Anthropological Association Principles of Responsibility
American College of Epidemiology Code of Ethics
American Medical Association Code of Medical Ethics
American Medical Informatics Codes of Professional and Ethical Conduct
American Psychiatric Association Code of Ethics
American Psychological Association Code of Ethics
Public Health Leadership Society Principles of the Ethical Practice of Public Health
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International Codes of Ethics
•
•
•
•
•
•
•
•
•
Declaration of Helsinki
International Ethical Guidelines for Biomedical Research Involving Human Subjects
International Federation of Social Workers Statement of Ethical Principles
International Ethical Guidelines for Epidemiological Studies
International Medical Informatics Association Code of Ethics for Health Information
Professionals
International Society for Environmental Epidemiology Ethics Guidelines
Nuremburg Code
World Health Organization Ethics
World Medical Association International Code of Ethics
Case Study
Your research team is collaborating with an Iranian research team on why people choose to donate their
organs to transplant patients. In the United States, organ donation is an altruistic practice, where
people donate their kidneys for no financial gain. However, in Iran, there is a program that
compensates living-unrelated renal transplant donors for the donation of their kidney.
What ethical considerations must you account for in this project? How will you address differences in
ethical codes and guidelines between you and your collaborators? Considering the differences between
the culture here in the Unites States and that in Iran, how will you navigate these differences in a
culturally sensitive manner?
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Appendix E: Health Sciences Module
Conflicts of Interest
Goals
After reviewing the information in this section, you should be able to:
•
Understand the definition of conflict of interest
•
Understand the importance of conflict of interest and how it might hinder scientific progress
and harm objectivity
•
Explain ways to address conflict of interest
At the end of the module, you will review two case studies and complete an exercise to demonstrate
your understanding of this material.
Conflicts of Interest in the Health Sciences
Collaborators must be clear, open, and honest regarding the purpose, methods, outcomes, and funding
sources for their research. Researchers must also disclose any conflicts of interest to their collaborators
and research subjects. Competing obligations between colleagues, participants, students, employers,
and sponsors are always present in research (American Anthropological Association, 2014). Obligations
to research participants, especially those in vulnerable populations, should always come first.
The different relationships involved in research collaborations may create conflicting or completing
obligations. The vulnerabilities of individuals, populations, or cultures are often in contrast with the
asymmetric power differentials implicit in these relationships, especially on the behalf of the
researchers (American Anthropological Association, 2014). Researchers must address these conflicts by
identifying and disclosing these power differentials and competing obligations.
What is Conflict of Interest?
A conflict of interest is any competing obligation or interest that could lead to competing
responsibilities or bias. There are two main types of conflicts of interest: financial and non-financial
(Antonuccio, Danton, & Mcclanahan, 2003; Greenwald, Poehlman, Uhlmann, & Banaji, 2009; Levinsky,
2002). Financial conflicts of interest include cases in which a researcher serves as a consultant for a
company or receives funding from the industry to conduct research. Nonfinancial conflicts of interest
include cases where a researcher's political, religious, and theoretical beliefs influence publishing or
funding decisions. Although both of types are serious, major funding organizations and other scholarly
research focus on financial conflicts of interest.
Consider this:
Your research explores the relationship between reproduction rates and uranium pollution. Your
hypothesis is that a local uranium plant is actually contributing to the low birth rates, and if the pollution
was mitigated, the reproduction rates would increase. A possible source of funding is an internationally
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Appendix E: Health Sciences Module
known drug compa ny that wants to test the effectiveness of Drug XYZ on the production of Hormone A,
which increases fertility and is essential for a healthy pregnancy, according to their claims and initial
tests. One of the test populations for your research is a small community in Central America, located
next to a uranium plant, with a historical record of low fertility and pregnancy rates.
Do you accept the funding? What if your research finds no significant effect of pollution on
reproduction rates? How would you address your personal bias that women should not take the drug?
What other biases and conflicts of interest could arise?
Conflicts of interest are not always black and white. The example above includes both financial and nonfinancial conflicts of interest. While conducting resea rch, you and your collaborators will each have
different research obligations and expectations. Disclosing these possible conflicting obligations and
expectations is an important aspect of ethical and transparent research.
Guidelines
Institutions, government agencies, and funding agencies all have guidelines for identifying and disclosing
conflicts of interest. Always review your professional association's and conflict of interest regulations or
guidelines before beginning research . Here are a few examples of guidelines:
Conflict of Interest Guidelines
•
Conflicts of Interest (NIH)
•
Ethical Guidelines for Managing Conflicts of Interest in Hea lth Services Research
•
ABOR Conflict of Interest Po licy
•
WMA Statement on Conflict of Interest
•
GRU Individ ual Conflict of Interest Policy
Addressing Conflicts of Interest with International
Collaborators
Researchers are obligated to identify and disclose all conflicts of interest to the different parties
participating in the resea rch project. Researchers must identify potential and real conflicts of interest,
which may change throughout the course of the research project. Remember, not all countries define
conflicts of interest in the same way. International collaborators will need to discuss what constitutes a
conflict of interest in their home countries o r for their funding agencies. Accounting for these
differences, each co llaborating scientist will need to disclose and discuss their conflicts of interest at the
start of the project, as well as any that arise during the course of the research.
When conflicts between ethical standards and expectations arise, researchers must explicitly disclose
their ethical obligations and develop a plan to move forward. In their roles as researchers, teachers,
mentors, and experts in their field, scientists are responsible for conducting ethical and transparent
research that does not unfairly benefit one group at the cost of another.
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By establishing the scope of the project and the rights and responsibilities of the researchers and
research subjects and disclosing any and all conflicts of interest, researchers can maintain an open and
honest relationship throughout the research project.
Case Study
Case Study #1
One of your colleagues is asked to review a publication from one of your international collaborators in
Africa . You did not actually work on this project with your collaborator, but you have a long-standing
relationship with this collaborator on other projects and are about to start work on another project.
The project reviewed by your colleague involved comparing the health and mortality rates of children
raised with private sanitation in their homes with those raised with access only to public sanitation.
While reviewing the paper, your colleague notices that a private company involved in building public
sanitation in India funded a large portion of this collaborator's research. The publication will be used by
the African government in their decision to begin funding private sanitation systems in the homes of
families with small children.
The results of the survey show no significant difference between the health or mortality rates of
children raised in home with sanitation when compared with children raised in homes with no sanitation
system and does not recommend funding private sanitation systems in the homes of sma ll children. You
know that your collaborator was raised in a home with no private sanitation system. Your colleague
tells you that he is questioning the validity of the data, as the results overwhelming favor non-private
sanitation systems.
Questions to consider:
•
What type of biases and conflicts of interest could your international collaborator have?
•
Discovering a possible discrepancy in the results and their interpretation, w hat are you obligated
to do? What should your colleague do?
•
How will you ensure that all conflicts of interest are disclosed and addressed in your upcoming
research project with this collaborator?
Exercise #1
To prepare for the in-person portion of this training, please read this articl e (Hartocollis, 2010) about a
conflict of interest involving a hospital employee.
Questions to consider:
•
What were your thoughts on the five digit fine that was given because of the conflict of
interest?
•
Do you think that the conflict of interest was a conflict of interest? If not, be prepared to argue
your point.
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Appendix E: Health Sciences Module
Case Study #2
The impact of community dynamics on conducting scientific research in sub-Saharan Africa**
Clement A. Adebamowo, University of Ibadan Ibadan, Nigeria
Case Description:
An international, multicenter, collaborative research project involving researchers and participants from
developed and developing countries will be organized to obtain anonymous blood samples from family
trios- father, mother and a child aged more than 18 years of age-in communities throughout the
world. Blood samples will be transformed into cell lines and stored in perpetuity at a location in one of
the developed countries participating in the research. Molecular biologists will use the blood samples to
create a new database of human genetic variation. Both the database and the cell lines from which they
were generated will subsequently be available for secondary use by any researcher from any- where in
the world, provided that the researcher submits a protocol approved by his/her institution's IRB and the
IRB of the storage center. Such secondary uses of the resource include studies of gene-disease
association, pharmacogenomics, and population studies. Funding for all sites, including low- resource
countries, was provided by some of the high- and middle-income countries involved in the research,
including the component carried out in low-resource countries.
Given the nature of this research, no direct benefit is expected to accrue to the participants in either the
developed or developing countries, other than compensation for transportation and lost wages
commensurate with the standard of the environment where the study is being conducted. There is no
doubt, however, that citizens of developed countries are more likely to be the first to benefit from the
outcome of secondary research that may be conducted using this resource. In view of this, as well as the
importance of genetic research in general and the risk of population stigmatization, extensive
community engagement was planned to educate all participating communities about the research. This
was followed by individual recruitment with individual informed consent.
As part of the community engagement process, community advisory boards (CABs) were established.
CABs are mandated to provide oversight for all aspects of the study, including community engagement,
sample collection, subsequent use of the samples, as well as assessment and distribution of any benefits
derived from the study.
At one of the sites in a developing country, a newly democratic nation with equal proportions of
Christians and Muslims and where religious tensions frequently lead to civil unrest, the study protocol
was followed and the community, at a town hall meeting, nominated seven members, including the
chief, to the CAB. The other nominees were community leaders (men and women) representing
different religions, and trade and civil associations. The research team nominated two members, neither
of whom were members of the community and one of whom was an experienced physician able to
guide the committee on medical issues .
At the first meeting of the CAB the board decided to elect a chairman . The closed election was
conducted democratically and resulted in the election of a member of the community other than the
chief to chair the CAB. Only members of the board nominated by the community voted. The result was
accepted by board members and their first meeting proceeded without incident.
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At the next town meeting, the chief gave feedback on the activities of the CAB, the election and its
result. Many members of the community expressed dissatisfaction with the result of the election and
were deeply disturbed about the composition of a committee that included their chief in what they
perceived as a subordinate role. Some were also concerned that the newly elected chairman was an
"official" of a particular religion and believed this might limit his ability to mobilize certain sections of
the community. In addition, there was concern that he might not be adequately sensitive to the
interests and aspirations of members of the community who belonged to alternative cultures and
religious traditions. These concerns were so serious that they threatened to halt the research.
The research team came up with an innovative solution that assured the community of the continued
supremacy of the chief while respecting the outcome of the election. The chief was made the "chief
executive" of the overall study, with responsibility for overseeing all community-related activities
associated with the research. The chief would also be consulted in all matters and decisions reached by
the CAB. This solution was accepted by members of the community and the study proceeded
uneventfully.
** in Marshall, Patricia L. Ethical Challenges in Study Design and Informed Consent for Health Research in
Resource-Poor Settings. Geneva, Switzerland: World Health Organization, 2007. Internet resource. Case
Study, Pages 44-45. Retrieved from:
http://whglibdoc.who.int/publications/2007/9789241563383 eng.pdf
Exercise #2
Questions to consider:
1.
How would you obtain information about cultural and community dynamics and power
2.
3.
structures prior to starting research?
How would you address the conflicts of interest as they arise?
What do you think about the research team's decision to make the chief "chief executive of the
overall study? What are the benefits of this decision? What are the costs?
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Appendix E: Health Sciences Module
Publication Practices and Responsible
Authorship
Goa ls
After reviewing the information in this section, you should be able to :
•
Define authorship and plagiarism
•
Understand guidelines and criteria for establishing authorship and authorship order
•
Define plagiarism and understand how it can be avoided
•
Summarize common authorship issues in the health sciences
•
Explain authorship in the context of international collaborations
At the end of the module, you will review a case study and complete an exercise to demonstrate your
understanding of the material.
Publication and Authorship in the Health Sciences
Publications, especially those involving first authorship, play an important role in career advancement,
research grant awards, other awards and prizes, and provide prestige and respect for the authors.
Responsibilities also accompany this prestige and advancement. Author's responsibilities include
assuring the reliability of scientific work, adherence to research integrity responsible conduct of
research guidelines, declaration of any conflicts of interest, communication with journal staff, reviewers,
and editors, and the defense of their contributions to the research and publications (Smith & WilliamsJones, 2012) . In single authorship papers, the responsibi lity and credit is easily determined, but
becomes more complex in the case of multiple authors and researchers. Publication practices and
assigning authorship in health sciences research should be addressed openly and fully at the beginning
of a collaborative research project, especially those involving international collaborators.
These issues become increasingly more complex in international contexts where multiple researchers
and thus authors with different cultural and social practices contribute to the research and publication
process. This section will cover topics related to publication practices and responsible authorship in
international contexts and how they can best be addressed when assigning authorship that is reflective
of all the different contributions.
What is Authorship?
Authorship is a very complex issue, involving everyone contributing to the research project, from
development, through data collection and analysis, to the final written product. Authorship should
acknowledge all contributions to the research, writing, and other related activities when determining
authorship for a publication. Researchers are obligated to give appropriate credit students and
employees for their ideas and contributions.
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Authorship Resources
•
Instructions to Authors in the Health Sciences
•
Scholarly Communication
Videos on Authorship
•
•
Authorship Guidelines
What is Peer Review?
Criteria for Authorship in the Health Sciences
Authorship assigns responsibility and gives credit for intellectual work on a project and publication.
According to the Harvard Medical School Authorship Guidelines (1999),
Authorship practices should be judged by how honestly they reflect actual contributions to the
final product. Authorship is important to the reputation, academic promotion, and grant
support of the individuals involved as well as to the strength and reputation of their institution.
These basic guidelines were established by the Harvard Medical School (1999) and are applicable in
most health sciences research settings and situations :
1.
Everyone who is listed as an author should have made a substantial, direct, intellectual
contribution to the work. For example (in the case of a research report) they should have
contributed to the conception, design, analysis and/or interpretation of data. Honorary or guest
authorship is not acceptable. Acquisition of funding and provision of technical services, patients,
or materials, while they may be essential to the work, are not in themselves sufficient
contributions to justify authorship.
2. Everyone who has made substantial intellectual contributions to the work should be an author.
Everyone who has made other substantial contributions should be acknowledged.
3. When research is done by teams whose members are highly specialized, individuals'
contributions and responsibility may be limited to specific aspects of the work.
4. All authors should participate in writing the manuscript by reviewing drafts and approving the
final version.
5. One author should take primary responsibility for the work as a whole even if he or she does not
have an in-depth understanding of every part of the work.
6. This primary author should assure that all authors meet basic standards for authorship and
should prepare a concise, written description of their contributions to the work, which has been
approved by all authors. This record should remain with the sponsoring department.
The University of Kentucky (2011) also provides the following guidelines for establishing authorship:
All authors listed should have made a substantial intellectual contribution to the work; this
includes concept/design, acquisition of data, or analysis/interpretation of data. Other
contributions should acknowledge, but may not lead to authorship .
2. All authors should participate in writing the manuscript by reviewing drafts and approving the
final version.
1.
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3.
4.
The senior author (Pl) must check all the original data that was generated by the lab or group
and take primary responsibility for the work as a whole.
Order of authorship will va ry depending on the field of study and/or type of work (basic science
vs. clinical); the authors should decide this order together at the initiation of the work.
Order of Authorship
There are different ways to determine the order of authorship, and they differ across disciplines,
research groups, and countries. Always review authorship policies for any funding agencies or foreign
countries where you conduct research. Authorship policies often include (Harvard Medical School,
1999):
•
descending order of contribution
•
placing the person who took the lead in writing the manuscript or doing the research first and
the most experienced contributor last, and
•
alphabetical or random order.
While some understand a particular order to have significance, there is no genera lly agreed upon
meaning for author order. This makes it difficult to determine the level of contribution to research or
publications based solely on author order.
Some guidelines for establishing author order (Harvard Medical School, 1999):
1. The authors shou ld decide the order of authorship together.
2. Authors should specify in their manuscript a description of the contributions of each author and
how t hey have assigned the order in which they are listed so that readers can interpret their
roles correctly.
3. The primary author should prepare a concise, written description of how order of authorship
was decided.
Always discuss authorship issues early in the research process and with everyone involved . Speaking
frankly about responsibilities and contributions will decrease the chance of iss ues later in the research
and writing process. If a dispute or issues about authorship does arise, the authors should discuss the
issue and reach an agreement.
Plagiarism
Plagiarism is a form of misconduct and well-known among U.S. students and researchers . Plagiarism is
defined as the appropriation of another person's ideas, processes, results, or words without giving
appropriate credit (Steneck, 2007).
When engaging in international collaborative research, remember that people may have different
definitions about what constitutes plagiarism. What constitutes plagiarism should be discussed prior to
beginning the research project to avoid possible issues in the future. In a recent review of 2,047
biomedical and life science research publications through May of 2012, nearly two thirds of all
retractions were because of misconduct, including fraud or suspected fraud (Fang, Steen, & Casadeva ll,
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Appendix E: Health Sciences Module
2012). Plagiarism and duplicate publication exists in countries that do not have long research histories
(e.g., China, India, and Turkey), and such misconduct is often found in low-impact journals. One reason
for these types of misconduct may come from the pressure to publish in English journals. Please review
the plagiarism case of the Turkish physicists below.
•
Turkish Physicists Face Accusations of Plagiarism
•
Bechhoefer's Response
Another recent article (Ana, Koehlmoos, Smith, & Yan, 2013) examining research misconduct found that
Brazilian researchers regarded copying text as not very serious and may arise because of the difficulty of
writing in English scientific journals. Another form of misconduct comes in the form of "self-plagiarism"
or the covert reuse of already published data or even of one's own portion of text that has already been
published (Roig, 2010).
Please review the NAU Student Handbook and the Academic Integrity Policy for more information on
how NAU defines and deals with plagiarism.
Video Resources
•
•
Tips to Avoid Accidental Plagiarism
How to Avoid Plagiarism - 5 Top Tips
•
Computer Program Helps Colleges Fight Plagiarism
Publication and Authorship Issues in the Hea lth Sciences
Common issues of authorship that arise in research publications include determining the order of
authors' names and the significance of the different contributions to the publication. Health sciences
research already addresses problems associated with the publication practices, but there is little
guidance regarding allocating credit in multi-authored publications. These issues are increasingly
complex in instances where there are numerous authors, and the responsibility for research is divided
among authors. To correctly allocate credit to contributing researchers and authors, all contributions
and responsibilities, not just the obvious ones, must be reviewed and evaluated (Smith & WilliamsJones, 2012). Although there is widespread agreement that authorship order should be awarded on the
basis of intellectual contribution, not all parties are included in this, especially graduate students. The
activities considered most worthy of author credit include developing the idea for the study and writing
the paper, followed by designing the study and analyzing the data. Data collection and entry are viewed
as relatively unimportant and more worthy of a footnote.
Osborne & Holland (2009} present an overview of a survey on how authorship and authorship order is
determined in scientific publications. As research becomes more complex and interdisciplinary with
multiple authors and a collaborative "team science" approach, specific authorship guidelines and
procedures are necessary. International collaborations add a level of complexity with different cultural
norms and practices surrounding these issues.
Status and power, two important variables in all cultures, can play a large role in determining authorship
and order. Authorship is often given to individuals because of their position or title, a It hough they did
not contribute to the research, while students who did contribute to the research do not receive credit
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Appendix E: Health Sciences Module
because of their position. In the U.S., the common practice is not to account for seniority when
establishing authorship, but in some international countries, authorship addresses seniority, with those
in higher positions within agencies and institution receiving first authorship without contributing to the
research or publication. In the health sciences, first authorship is often seen as more prestigious, while
in other disciplines authorship is listed alphabetically, which can disadvantage researchers with names
at the end of the alphabet, as articles with more than five authors are truncated for publication.
In their review, Osborne & Holland (2009) summarize a "substantial" contribution, which could include
some combination of one or more of the following:
1.
2.
3.
4.
Conception or design
Data collection and processing
Analysis and interpretation of the data, and/or
Writing substantial sections of the paper
Video Resources
•
Authorship and Conflicts of Interest
•
Ghost and Guest Authorship Still a Concern for Medical Journals
•
Authorship, Plagiarism, and Conflict of Interest
Research Study Contracts
To avoid authorship issues, researchers should discuss how contributions to the research and
publication will be addressed in authorship of the submitted publication prior to starting the
research project. In student-faculty collaborations, the faculty member is responsible for initiating the
authorship conversation, but the student should address the topic if the faculty advisor does not.
A research study contract can clarify roles and responsibilities in research. The research study contract
includes a list of all of the tasks included in a research project, including literature review, hypothesis
generation, research design, Institutional Review Board paperwork and approval, data collection, data
analysis, and writing. Researchers then use a checklist to facilitate a discussion of each task and who is
responsible for each task. Other examples of forms used to establish author order and research
responsibilities include:
•
Point and Methods Assignment for Activities Associated with Research Manuscript/Poster
•
Contract Regarding Publication Intent
Although you may create a research study contract and determine authorship early in the research,
remember there are legitimate reasons why authorship might change throughout the project.
Collaborators have ongoing discussions about the project and the research contract should aspects of
the project change. For example, a student who agreed to be second author may take the lead on a
substantial paper revision and his/her contributions may warrant first-authorship. Alternatively, if a
member of the team drops out, assignments might shift and a new discussion about responsibility and
authorship is necessary.
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Appendix E: Health Sciences Module
International Collaboration and Authorship
When conducting research with international or interdisciplinary collaborators, it is important to
consider that different cultures and disciplines may have different authorship guidelines. Researchers
should review their professional organizations' recommendations and guidelines regarding responsible
authorship and publication practices. When reviewing the guidelines and recommendations, consider
how these practices may be affected by physical distance and cultural differences when collaborating
with international partners.
Additional Readings
•
Authorship ethics in global health research partnerships between researchers from low or
middle income countries and high income countries
Case Study
You received funding to travel to Russia to collaborate on a research project that will compare diet to
life expectancy. You will work with three Russian researchers and one doctor from Bangladesh. The
team will employ three graduate students to compile data and initially analyze the report. Everyone will
contribute to the project and the publication, but you are unsure that the author order will be. What
should you do?
Exercise
Describe the steps a researcher would take to insure responsible authorship order in a situation where
there are multiple authors from different countries.
In response to a hypothetical research situation, construct a letter clarifying authorship and publication
expectations in a culturally sensitive manner.
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Appendix E: Health Sciences Module
Data Management: Access, Sharing, and
Exchange
Goals
Once you have completed the data management and sharing section of this module, you should:
•
Understand the basics of data management and the growing challenges that large data sets
create for data management and archiving
•
Describe the issues that can surround data ownership and how t hese issues can be even more
complicated in international collaborations
•
Describe several data sharing policies and how you would apply them to your own
collaborations
You will review a case study and complete a brief exercise after completing this module.
Dat a M anagement in the Health Sciences
In the health sciences, the issues of data management, including acquisition, protection, archiving, and
sharing, are increasingly important. Innovative ways to manage data advance the reliability,
reproducibility, and validity of empirical research to align research values with academic scholarship.
Researchers have the ethical res ponsibility to ensure the integrity, preservation, and protection of their
data and work (American Anthropological Society, 2014).
Large databases containing publicly accessible data are now available and in use by individuals who
played no role in collecting the data. Researchers can post large data sets on line, widely disseminating
the data without the traditional peer-review or quality control procedures used by la rge, public
databases. This rapid dissemination provides tremendous opportunities for scientific advancement, but
new mechanism s for ensuring data quality remain necessary.
International differences in data collection and management policies can complicate data management,
particularly in the era of "big data," and the opportunities it presents for synthesis and understanding
across international boundaries. Big data refers to any collection of data sets so large and complex that
it becomes difficult to process using on-hand data management tools or traditional dat a processing
applications.
Data M anagement Plan: Collecting, Recording, and
M aintaining Dat a
When collecting and recording data, the researcher is res ponsible for establishing a data management
plan that protects the resea rch participants and ensures the data will not be used in an unauthorized
manner. Researchers should determine how funding sources, employment agreements, and
20
Appendix E: Health Sciences Module
agreements with collaborators affect the different stages of data management, including ownership,
storage, and shari ng the data. This includes establishing by whom and how the data will be stored,
preserved, shared, or disposed of in the long term. Researchers should also consider any possible uses
of collected data and materials when obtaining permission and consent from research participants.
Considerations when creating a data management plan (UCONN, 2014):
•
•
•
•
•
Data description
o What kind of data will be produced?
o Is it live or ready to be archived?
o What file formats will be used?
Metadata
o How will you describe the data to make it discoverable?
o What documentation is needed to make the data useable?
o What metadata standards will you use?
Access and Reuse
o Have you established a timeline for when the data will be available?
o Are there confidentiality issues?
o Do any regulations apply to the data (for example HIPAA)?
o Should the data be restricted or embargoed for intellectual property reasons?
o Do you have the right to share the data if it is not produced by you?
o Are there any copyrighted materials associated with the data?
o Will the data be licensed?
o Who will be able to access the data?
o Who may be interested in your data in the future and what might it be used for?
o Are there any reasons not to allow re-use?
Archiving and Preservation
o How long should your data be kept?
o Have you identified a repository or archive in which to deposit your data?
o How will the data be prepared for long term preservation (if needed.)
o Will funding or other institutional commitments be required for preservation?
o What are the procedures for your intended long term data location for preservation and
backup?
o How will documentation and cu ration responsibilities be transferred from one entity to
another?
Transition or Termination of the Data Collection
o How long will your data be active?
o Who will manage it?
o Do you have a retenti on schedule or a schedule to destroy your data at some point?
o Is there a need to migrate or transition your data to another media or structure in the
future?
o Will data be destroyed after a specific time period? If so:
• Are there ethical or legal obligations for the secure removal of data after a
specific time period?
• How do you plan to destroy the data?
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Appendix E: Health Sciences Module
Health science researchers must also inform their participants of the data management plan, including
the collection, use, archival, and possible exchange or sharing of the research records. Open
communication concerning the use and possible reuse and exchange of the data contributes to a good
relationship with the research participants.
While collecting data, researchers should not plagiarize, fabricate, falsify, or knowingly misrepresent
information or its sources (American Anthropological Association, 2014). Always ensure the
confidentiality, protection, and security of all notes, recordings, samples, and other primary data during
the collection and maintenance of data. Remember, data and its analysis is subject to interpretation,
and this interpretation may vary between researchers, across disciplines, or in international contexts.
Data is always susceptible to differing and unintended uses.
Additional Resources
•
Data Management And Sharing FAQs
•
Create and Manage Data
•
Why Create a Data Management Plan?
•
Writing a Data Management Plan
Who Owns the Data?
Data is subject to the complex issues of ownership and stewardship. Whenever a disagreement or
conflict over ownership arises, the assumption is that the researcher owns his or her work product,
unless established otherwise (American Anthropological Society, 2014) .
Federal projects that result in the development of intellectual property are subject to the Bayh-Dole Act
of 1980. This legislation enables universities "to assume exclusive control over intellectual property
resulting from federally-funded research and development, for further development, transfer to
industry, commercialization, and provision to the public" (American Anthropological Association, 2014).
As a student working hard to collect data to test a hypothesis, the answer to this question might seem to
be a simple one - you own the data. However, this might not be the case depending on your project's
funding or where it takes place. Please read this page from the United States Office of Research
Integrity and determine how it applies to your research project.
Now, think about additional complexities that might arise if your project takes place at an international
location or if you have international collaborators who have invested significantly in the project, either
in terms of personnel, funding or both.
Archiving Data
Data can be stored and archived using a variety of methods. Data is often retained for a period of years
after its initial collection. Ensuring that the data remains valuable and usable requires careful archiving.
After spending considerable time and energy on a project, it may seem like you will never forget
methodological details. However, after even a few months, these details can be difficult to recall
22
Appendix E: Health Sciences Module
precisely. Archiving data requires archiving the data itself (primary data,) as well as information about
the data (metadata or secondary data).
A great deal of data now exist s in digital form. Software changes dramatically over the years,
sometimes rendering data stored in an older format inaccessible in a newer format. Public data
repositories can help solve accessibility problems, but the review the reference below for ways to
effectively manage data for the long-term (Borer, Sea bloom, Jones, and Schildhauer, 2009) :
•
Some Simple Guidelines of Effective Data Management
When storing data, the confidentiality of the research participants must be maintained. Digitization and
digital media are increasingly used for data storage, although paper copies and computer discs may still
be in use for older research projects. Preservation is easier with digital media, but so are duplication
and circulation. When determin ing how to preserve the data, researchers should find a balance
between maintaining the integrity of the data and the privacy of the participants.
•
Best Practice in Archiving Qualitative Data
Data Sharing and Reuse
Results should be disseminated in a timely manner, whether through publication or sharing data with
other researchers or the public. Funding agencies or sponsors may have specific guidelines for sharing
data. The National Institutes of Health has a .QQli£i for sharing data (2007). Under the requirements of
the Freedom of Information Act (United States Department of Justice), the Office of Management and
Budget revised the OMB Circular A-110 to ensure that all data be available to the public (1999). Other
agencies, federal and international, may have similar policies or requirements.
When sharing data with other researchers or the public, it may be appropriate to limit or restrict certain
aspects of the data dissemination, especially to protect the identity or cultural heritage or property of
the participants (American Anthropological Society, 2014). Shared data always has the possibility of
becoming widely available, even when the dissemination is limited. Protecting the confidentiality of the
data and the research participants is always the goal of the researcher when disseminating research.
Sometime, the most ethical decision is to not distribute the data.
Before collecting data, researchers should discuss how the data will be disseminated with the research
participants. Plan to share your results with the participants, especially if the results will be shared with
others. Limited or restricted data dissemination may be necessary to protect the safety, dignity, or
privacy of the research participants or to minimize the risk to researchers (American Anthropological
Society, 2014). However, whenever data is restricted in its dissemination, ethical issues may arise,
especially if the data is used by other researchers not involved with the original project.
Data is susceptible to differing and unintended uses, especially when data is shared w ith people who did
not work in the original project. Situations may arise where data and information should be minimally
modified or generalized to protect the identity of the research participants prior to sharing the data.
Modifying and generalizing the data could include the use of synonyms or unique identifying numbers
23
Appendix E: Health Sciences Module
for the participants. These small changes can protect the confidentiality and identity of the participants
when sharing data.
Public Data Repositories for the Hea lth Sciences
Here are a few examples of data repositories and lists of available repositories:
•
Agency for Healthcare Research and Quality (AHRQ)
•
Biomedical Informatics Research Network (BIRN)
•
DataBib
•
DataCite
•
Data Bank
•
Data Management & Curation
•
National Center for Health Statistics
•
Qualitative Data Repository
Case Study
Dr. Couch (United States) and Dr. Wong (China), co-Pis on a NSF funded project, are gathering data
diabetic patients in the United States, China, Australia, and Russia. They created a data plan that
involved Dr. Couch maintaining the data during collection and analysis, and Dr. Wong archiving the data.
After they published a paper on their findings, Dr. Wong was asked by a collaborator in France to use
the data in a different project. Dr. Wong gives access to the French researcher. Unfortunately, all of th e
participant data was made public in the Fren ch study.
Exercise
Write a brief paper answering the following questions:
•
How could the relea se of confidential data been avoided?
•
Should Dr. Wong consulted with Dr. Couch and the other researchers involved in the project?
•
If you were creating a data management plan, what would you consider?
24
Appendix E: Health Sciences Module
Additional Resources
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Appendix E: Health Sciences Module
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Appendix E: Health Sciences Module
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Appendix E: Health Sciences Module
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Appendix E: Health Sciences Module
Other Resources
Collaborative Research
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