As a professor of Epidemiology, my primary goal is to teach my students how to read, critically analyze, and apply the results of an epidemiological study to create healthy communities. I want to empower my students to read research papers from beginning to end (not just the Abstract and definitely not skipping the Methods section). I want them to confidently read the literature, determine for themselves the strengths and limitations of the study, and be able to communicate the findings and any applications of those findings to a group of community members without any knowledge of epidemiology.
And I want to invite all of you into my classroom (so to speak). I want to provide you with a guide to reading the epidemiological research and the opportunity to read, discuss, and apply the findings of epidemiological studies with me.
Together — with improved literacy and the ability to see the strengths and limitations that are inherent in every study — we can fight misinformation, spot disinformation, craft strategies to improve health, and create healthy communities.
Are you ready?
Do you want to learn how to read, analyze, and apply the epidemiological literature?
Let’s get started… (if you missed one of the first three posts — Rule #1, Three Things They Assume You Know, and The Canon of Epi — go back and read those first).
When it comes to conducting ethical epidemiological research, there are three things you need to know (yes, three things is my thing…) —
Federal & international law directs what can and cannot be done/what is ethical vs. unethical in any research project involving human participants.
These laws exist because terrible, terrible things have been done under the guise of research. Strict rules and multiple layers of oversight are necessary to ensure that studies are conducted ethically.
Being an ethical epidemiologist also means one does NOT manipulate the data and that analysis, interpretation, application, and communication of results is in line with what the data are saying (nothing more & nothing less).
NOTE — writing a post about ethics in research at this moment is hard. Dana-Farber Cancer Institute is facing facing allegations of data manipulation. The President of Stanford University just resigned after it was shown that he falsified data in studies dating back 20 years. Within the field of epidemiology and science (more broadly), we can no longer expect that all studies and all researchers are ethical.
I’m currently reading We Want Them Infected where the author, Dr. Jonathan Howard, notes (pg 29) —
“Before the pandemic, I didn’t apply this level of scrutiny to work of highly credentialed doctors at renowned medical schools. I believed such doctors made dedicated efforts to be both accurate and thorough, especially when communicating with the public…Now, I can no longer assume that many doctors accurately report basic facts or make a diligent effort to be nuanced and thorough…”
The laws that govern and the ideals put forth below concerning ethics, do NOT make our studies or researchers ethical.
I hope that you will read what is expected (and the history that we have created and must work to repair and make right) and use this knowledge as a lens through which to read the epidemiological research.
Laws that Govern Ethical Research
The code of ethics used by epidemiologists (and other researchers who study human health) is outlined in the Belmont Report. Written by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research the Report includes three guiding principles for conducting ethical research with human participants:
Respect for persons — individuals must agree to participate in a study voluntarily; they cannot be compelled, coerced, or forced to participate. They must also be given adequate information to make an informed decision about whether or not to participate.
Beneficence — Individuals conducting research on people have an obligation to each participant to (1) do no harm and (2) maximize benefits while minimizing harm. There are examples where the benefit to the individual is small and the risk is great, but the benefit to the community or common good is what outweighs the individual risk. For example, terminally ill patients may agree to participate in a clinical trial that might not save their lives, but what is learned from the trial might help other patients in the future. A balance must be struck between benefits and harms. Consideration must also be given to what could be lost if the research is not conducted. It is a delicate balance.
Justice — A researcher must be fair in selecting participants, and all participants in a study should be treated the same (we cannot provide incentives to one group of participants and not another, nor can we provide pain relief to some participants and not others). Additionally, all researchers conducting publicly funded research must ensure that the benefits of the study are available to all participants, including those who are unable to afford them.
The U.S. Code of Federal Regulations Title 45, Part 46, issued by the U.S. Department of Health and Human Services, requires that all research with human participants meets a set of ethical requirements. The law is organized into several subparts:
Subpart A (also known as The Common Rule): requires the creation of institutional review boards (IRBs) and mandates informed consent for participation in research studies. IRBs review ALL research proposals involving humans and the Board (not the researcher) determines if the research is ethical.
Subparts B–D: provide specific and detailed regulations for working with vulnerable populations, including but not limited to human fetuses, pregnant people, infants, children, and prisoners. If you want to conduct research within one of these groups, you have to do a lot of extra work to demonstrate that the research meets the ethical standards listed above (and this is hard because neither a fetus nor an infant can provide informed consent and prisoners have little autonomy). Conducting ethical research is challenging, and there is a lot of paperwork and there are many layers to the approval process.
One note about HIPAA… HIPAA (or the Health Insurance Portability & Accountability Act) for most of us is just the waiver we sign each time we seek medical care. Something about privacy… (details about what you are signing are here). Please note —
What does this mean?
It means, with approval from an IRB, unidentified medical records can be used for research purposes without the informed consent of patients. This allows for important research, such as this, to be conducted in a timely fashion because the researcher does not have to ask for informed consent from each individual. HIPAA allows medical records to be used for health research purposes with IRB approval.
Terrible, Terrible Things Have Been Done…
The history of research on humans is full of examples of the unethical treatment of human beings. During World War II, the Nazi government conducted research on humans in concentration camps. The US Public Health Service Study of Untreated Syphilis, which started in 1932, was one of the most unethical medical experiments of all time and has become a clear example of racism in medicine, public health, and human research (in the not-so-distant past).
These terrible, terrible unethical studies (and countless others, including this one related to the measles vaccine) have caused acute and long-term harm. People have died because of unethical research. And trust has been compromised. The unethical studies listed here happened in the not-so-distant past. And the damage has not yet been repaired or forgotten.
Being an Ethical Epidemiologist
American College of Epidemiology’s (ACE) Ethics Guidelines provide key duties and obligations defining how epidemiologists should act. In addition to conducting ethical research that ensures respect for persons, beneficence, and justice, epidemiologists are also expected to —
Maintain the public’s trust… Public trust is essential for surveillance, outbreak investigations, and research efforts. Epidemiologists should strive to involve community members in the design and conduct of a study, adopting a community-based participatory research approach. In other words, epidemiological research should be research conducted with the public and for the public; with communities and for communities.
Avoid conflicts of interest… Conflicts of interest, such as a financial interest, can affect scientific judgment and reduce scientific objectivity. This can influence how research results are reported. Potential conflicts must be acknowledged when research is submitted for publication and may even be required in the informed consent process. As consumers of epidemiological research, we should ask researchers about conflicts of interest and read the fine print of papers to see what the authors are disclosing about potential conflicts.
Model ethical behavior through communications… epidemiologists should model ethical behavior by example and by communicating ethical requirements to others for each study. In addition, epidemiologists should address and report any unethical or unacceptable conduct they encounter.
As a teacher, when I share datasets full of health information I’ve collected through my research with my students, I always take a moment (or two) to pause and remind them that each row represents a community member, cancer patient, or hospitalized COVID case with a family and a life and a will to be healthy again. We are not just running statistics. We are working to improve health and create healthy communities for each of these participants in our study.Be attentive to the communities we serve… Results of research studies should be communicated to community members in a timely manner, without censorship (and not behind a journal’s paywall), and without interference from outside parties. All communications should be clear, highlight what the epidemiologist is doing and why, and involve community members whenever appropriate.
That’s it… an overview of the ETHICS of epidemiology.
Next Tuesday we’ll move on to Reading the Methods Section…
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Do you have questions about ethics? Or the history of unethical research?
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Epi(demiology) Matters is written by Dr. Becky Dawson, PhD MPH — an epidemiologist, teacher, mom, wife, and dedicated yogi. She is a tenured professor at Allegheny College, Research Director at a community hospital, and an exclusive contributor (all things health & medicine) at Erie News Now (NBC/CBS). Her goal is to create healthy communities for all. She writes Epi Matters — first & foremost because epidemiology does matter (to all of us) and she hopes that each post will help to educate and empower readers to be healthy and create healthy communities.
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