Research & Publication Ethics

John Whyte, MD, PhDMoss Rehabilitation Research Institute & Thomas Jefferson University

Responsible Conduct of Research…Includes:• authorship;• data collection, analysis, and interpretation;

• intellectual property;• record keeping;• use of organisms;• conflicts of interest

We won’t talk much about:• Human subjects/IRB issues (you will get lots of exposure to this)

• Fabrication/falsification (the concept is straightforward)

Intentional vs. inadvertent

• The PI is responsible for being responsible (carelessness is no excuse)

• However, intentional violations generally have more severe consequences than inadvertent errors

• Open and honest communication and appropriate documentation can help to demonstrate that any errors made were not intentional

Some Illustrative Case Examples

Authorship

You are conducting a study on patients seen in the ED with concussions. You’ve met with the head of the ED to establish a system for enrollment and data collection. You deploy research assistants from your lab to the ED who do all the front line work. You invite the director of the ED to several research meetings but she is always too busy to participate. As your study is winding up, she asks to see your initial manuscript and is irate that she gets only an acknowledgement…

Data Collection/record keeping

A computer system collects reaction time data from subjects with brain injury for a study of attention. The raw data from the computer are reduced to a set of scores which are then entered by hand into an Excel database. When you get to the “macro” analysis comparing patients and controls there are some odd patterns, but when you go to look at the raw data you can’t find corresponding data…

Data Analysis and Interpretation

You’re comparing a new treatment to the standard of care using a parametric statistical technique. The new treatment is significantly better than the old, but there are several individuals in each group that are “outliers”. A non-parametric analysis gives no significant difference. Removing the outliers also eliminates the difference. Log transforming them retains the significant difference…

Use of Organisms (people)

You are doing a study in TBI that requires data on the duration of post-traumatic amnesia as a severity indicator. Many of your potential subjects have already cleared PTA before they consent to the study. Since recording of PTA is a non-invasive activity, you negotiate with your clinical colleagues to gather PTA duration for clinical purposes which will make it available to you once the subjects enroll…

Conflict of interest

• You are a busy clinician active in treating hypertonia with a novel injectible agent. You receive an unrestricted educational grant to study the pattern of use of the agent in clinical practice and associated outcomes. Because your time for the study is extremely limited, the company suggests a data management company that they’ve worked with before that may be able to manage and analyze the data for you…