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

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

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

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

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

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

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

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