Module 5 – Issues in Health Research
Description
Research ethics deals with standards of behavior that researchers are expected to adhere to.
Basically, these guidelines help to ensure the integrity of researchers' application of 'what is
right and wrong'. Ethical guidelines in research not only ensure the integrity of the process and
findings of the research, but also help to ensure that the subjects of the research are treated in
a responsible way, regardless of whether the research is on animals or humans. This module
also covers topics on cultural issues related to the conduct of international health research.
Learning Objectives
After completing this module, you should be able to:
1. Discuss the history and importance of ethics in health research;
2. Identify key health research principles and examples of situations where these are relevant;
3. Explain the principle of informed consent and the criteria or essential components in
meeting this ethical principle;
4. Discuss examples of research ethics principles, define research misconduct and how these
may be avoided;
5. Discuss emerging issues in international health research collaborations;
6. Develop a plan for research ethics relevant to the proposed research topic.
Content Outline
< History and Overview of Research Ethics Principles
< Informed Consent
< Research Misconduct
< Issues in International Health Research
Topic 1 - History and Overview of Research Ethics
The beginnings of research ethics emerged after World War II, as an offshoot of the Nuremberg
Trials for Nazi war criminals. The resulting Nuremberg Code identified 10 principles that were
violated by the doctors who conducted experiments on prisoners in concentration camps.
Learning Activity 1
What are the basic principles for conducting human research and what was the history on their
development?
a. Read the first section (“Research Ethics: Background and Definition”; pages 3-7) of the
Guide Book: A Guide to Research Ethics by the University of Minnesota Center for Bioethics
(2003).
[Link]
This section presents a brief history of research ethics. It also outlines the principles of the
Nuremberg Code -- a list of ten basic ethical principles that served as the foundation for
modern day ethical guidelines in the conduct of research on humans. This guide also covers
eight research ethics issues: authorship, plagiarism, peer review, conflicts of interest, data
management, research misconduct, research with animals, and research with human
subjects.
b. Watch the video “Research Ethics” (3:22 minutes) by the Yale University School of
Medicine (2011). Presented by Dr. Robert J. Levine.
[Link]
This video gives a brief narration of how research ethics became prominent in the United
States, and the different events that led to the development of ethical guidelines for
research.
Research ethics covers a set of principles. It is important for a researcher to be familiar with
each of these, and the possible situations where these may be encountered during the research
process.
Learning Activity 2
Read the online article “What is ethics in research and why is it important?” by Dr. David B,
Resnik (2015).
[Link]
The article describes research ethics in general and cites the importance of the application of
ethical principles in the conduct of research. The author identifies and summarizes 16 key
principles and policies taken from various ethics references and sources. It also presents
examples of cases to help illustrate the application and interpretation of the code of research
ethics.
Quite often, the application of ethical principles in research to avoid research misconduct is
straightforward. However, in real-world settings and organizational circumstances, a number
of practices by researchers might fall into a "grey area." In Dr. Resnick's paper, these
examples are listed as "other deviations" -- he cites that these are usually considered
unethical but might not fully constitute research misconduct. These situations sometimes
present ethical and moral dilemmas for researchers.
Guide Questions:
1. Discuss the history of research ethics. What are the three landmark milestones/ reports
that serve are the main guideposts for ethical research up to the present?
2. Describe each of the 16 research ethics principles identified in the Resnik article. Which
of these principles resonate the most with you?
3. What are some deviations from good practice that could be considered unethical, as
described in Dr. Resnick's paper?
3. Reflect on the “stressful environment theory.” To what extent does this kind of
environment exist in your work setting? What are some possible ways that you or your
institution might be able to address or mitigate these?
Topic 2 - Informed Consent
Research dealing with human subjects invariably must consider the key principle of informed
consent. This not only involves getting a signed consent form from each research participant but
should include providing all the necessary information about the research, the role of the
participant, as well as possible benefits and risks in their participation.
Learning Activity 3
a. Watch the video “Dialogues in Behavioral Health Research Ethics Informed Consent” (27:19
minutes) from the Missouri Institute of Mental Health channel (2013).
[Link]
The video discusses informed consent as a “cornerstone principle within research ethics.” It
presents the range of information that should be provided to all research participants in the
process of getting their consent to avoid any form of coercion in the recruitment of human
research subjects. Information is provided by several resource persons in a dialogue format.
b. Read the journal article “Informed consent in international research: the rationale for different
approaches” by Krogstad et al. (2010).
[Link]
This paper highlights differences between developed and developing countries, and how
these differences in context might influence the application or use of informed consent.
Specifically, it highlights some challenges in developing countries that could modify the
processes used in securing informed consent from individuals or communities.
Guide Questions:
1. What is informed consent and what kinds of information should research investigators
convey to potential participants to meet the requirements of informed consent?
2. What are some practical challenges or obstacles that have been encountered in
applying the ethical principle of informed consent?
3. Discuss the significance of cultural differences in applying informed consent, and how
might the concept of autonomy vary in different cultures?
4. What are some instances where “proxy consent” may have to be obtained?
5. Discuss some examples where subtle pressures might be brought to bear by
researchers on potential participants. How might this be avoided?
6. What are some challenges in applying informed consent for research conducted in
developing countries about the provision of relevant information to potential participants
in a research study?
7. Discuss the issue of financial incentives for participation in a research study. How would
financial compensation in the context of limited access to health care be seen as
important?
8. What are some challenges about the right of refusal and randomization, particularly
among subjects with low literacy or education levels?
9. In the paper by Krogstad et al., what do the authors recommend about the application of
informed consent in countries or settings with different cultures, social traditions, and
literacy?
Topic 3 - Avoiding Research Misconduct
The Office of Research Integrity (ORI) of the United States Department of Health and Human
Services defines research misconduct as “fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting research results.”
Link: [Link]
The ORI characterized its definition by stating the following:
(a) Fabrication is making up data or results and recording or reporting them.
(b) Falsification is manipulating research materials, equipment, or processes, or changing or
omitting data or results such that the research is not accurately represented in the research
record.
(c) Plagiarism is the appropriation of another person's ideas, processes, results, or words
without giving appropriate credit.
(d) Research misconduct does not include honest error or differences of opinion.
Learning Activity 4
Watch the video “Research Ethics for Health Professionals” (33:28 minutes) by Dr. Katrina
Bramstedt, Bond University Medical Program, Australia.
[Link]
This video explains the role of a human research ethics committee, identifies guidelines for
conducting research in human subjects, cites the basic components of a research protocol,
explores ethically sensitive areas in conducting research with human subjects, and explains
the types of research misconduct.
Learning Activity 5
Practical exercise: Consider the research topic that you have proposed/planning to undertake
for IH 300. Identify and explain the research ethics considerations that you must include in your
proposal. Use the following guide questions:
1) What are the ethical principles that must be considered in your proposed research?
2) How will informed consent be obtained? (if dealing with human participants)
3) What are the data collection methods/interventions that will be used? Are there any
ethical implications or considerations related to the proposed method(s)?
4) How will privacy or confidentiality of the subjects be ensured? (human subjects)
5) What are the risks that research participants might be exposed to? How will potential
risks be minimized (if applicable)?
6) What are the possible benefits for the research participants (if any)?
7) Are there any ethical considerations that are too challenging that make you rethink your
proposed research topic/problem?
Topic 4 - Issues in International Health Research
Collaborative research across international boundaries has widened opportunities for
researchers from high income countries to engage with those in low and medium-income
countries, especially in health research. Some key issues and lessons from conducting
international health research have emerged. Specifically, controversies in international health
research have arisen as a result of debates around uneven participation between developed
versus developing countries.
Learning Activity 6
Read the journal article "Ethics in international health research: a perspective from the
developing world" by Zulfiqar Ahmed Bhutta in the Bulletin of the World Health Organization,
2002;80:114-120.
online article - [Link]
96862002000200006&script=sci_arttext&tlng=en
pdf version - [Link]
The author of this paper writes about ethical conduct and review of international health research
and the ensuing debates among ethicists and researchers on some key issues. He makes the
observation that "debate has largely taken place among ethicists and researchers in
industrialized countries" and argues that the "views of public health practitioners and
researchers from developing countries have been underrepresented."
In the paper, the author cites the AIDS Clinical Trials Group study as an example where ethical
controversies and issues have been the source of debate. He goes on to discuss the feasibility
of having guidelines for ethical conduct of research based on national or international standards.
Three specific research ethics issues were discussed in detail: 1) community participation;
2)Prior agreements and benefits of research; and 3) standard of care and the use of placebos.
Finally, the paper proposes four major measures in moving forward.
Another key issue in international collaboration on health research is on the ethics of authorship,
particularly when language and power differences between different researchers exist.
Learning Activity 7
Read the journal article “Authorship ethics in global health research partnerships between
researchers from low or middle-income countries and high-income countries” by Smith, et al
(2014).
[Link]
This paper discusses the issue of fair distribution of authorship credit within international
research partnerships. The authors examined some issues regarding authorship in
collaborative partnerships between researchers from high income countries and those from
middle and low-income countries. It recommends some concrete steps/actions that may help
to mitigate the issues identified.
Guide Questions:
1. What is the main issue being raised by Bhutta in his paper? In the example of the ACTG
Study, why did the use of placebo arms in the design of the study lead to "acrimonious
debate" and was seen as a violation of fundamental human rights by some researchers?
2. Discuss the issues raised in the paper about: 1) community participation; 2) prior
agreements and benefits of research; and 3) standard of care and the use of placebos.
2. What are four key authorship issues discussed in the paper by Smith et al.? Discuss
each of these issues and how might these be addressed or mitigated