2. Ethical Issues in Medical Writing
Joseph S. Solomkin, MD, FACS, FIDSA
Professor of Surgery (Emeritus)
University of Cincinnati College of Medicine
CEO, OASIS Global

3. Outline
The major ethical dilemma in medical research is whether to address a problem with the optimal methods to do so
Observational reports
Randomized controlled trials
Conflicts of interest
RCTs as models for ethical and high quality clinical research

4. What are the ethical principles in research involving humans?
respect for persons
privacy, confidentiality
autonomy - make own decisions
informed consent
RESPECT FOR PERSONS – every person is an individual, with rights and individual dignity,
they are entitled to your respect just for being an individual.
In the context of research issues of privacy and confidentiality need to be
safeguarded to ensure this principle is upheld.
AUTONOMY – deals with the fact that individuals have the right to self determination
– make decisions that will affect them. In the context of research, in order to make decisions, what does and individual need to make an informed decision – information:
consent based on adequate information is essential.
12/6/2018
ethics in research involving human subjects

5. What are the ethical principles in research involving humans?
beneficence promotion of well being
maximize benefit
non-maleficence - do no harm (commission or omission)
minimize harm
BENEFICENCE – refers to promoting well being. In the context of research,
this refers to the responsibility of the researcher to maximise the potential benefits of the study for the participants.
NONMALEFICENCE – refers to the requirement to do no harm.
Applied to research, this refers to the researcher’s responsibility
to minimize the potential for harm – or the potential risks
12/6/2018
ethics in research involving human subjects

6. Intellectual Conflicts of Interest
Intellectual conflicts of interest are defined as “academic activities that create the potential for an attachment to a specific point of view that could unduly affect an individual’s judgment about a specific recommendation”.
Such interests are appropriate in themselves, but may conflict with the interests of research subjects and patients
These conflicts are more subtle and yet more pervasive than financial conflicts of interest cannot be eliminated

7. Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs)
Establishing transparency
Management of conflict of interest (COI)
Guideline development group composition
Clinical practice guideline-systematic review intersection
Establishing evidence foundations for and rating strength of recommendations
Articulation of recommendations
External review
Updating

8. GRADE: Elements in the Risk of Bias Assessment
Selection bias
Random sequence generation
Allocation concealment
Performance bias
Blinding of participants and personnel
Detection bias
Blinding of outcome assessment
Attrition bias
Incomplete outcome data
Reporting bias
Selective reporting (ITT, CE)
Other bias
Other sources of bias

9. The GRADE Process
Magnitude of effect: Effect measure large RR >2 or <0.5
(based on consistent evidence from at least 2 studies, with no plausible confounders): upgrade 1 level
very large effect measure RR >5 or <0.2 (based on direct evidence with no major threats to validity): upgrade 2 levels