Research lecture 5

Dr. Sorin Ioacara

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing

research, or in reporting research results. Fabrication is making up data or results and recording or reporting
them. 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. Plagiarism is the
appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

Minimal risk can be defined as the probability and magnitude of harm or discomfort are not greater than
those ordinarily encountered in daily life or during the performance of routine physical or psychological
examinations or tests. Subjects included in observational studies are usually at minimal risk. Subjects
included in interventional studies are usually at a higher risk than the minimal risk.

Informed Consent Formulary (ICF) must be signed by all research subjects considered at a risk higher than
the minimal risk, and in some circumstances when the risk is minimal. The patient or legally authorized
representative signs the ICF. No coercion or undue influence must be exercised. ICF is obtained by
Investigator/Staff trained and authorized by the Ethics Committee. It must be written in a language
understandable to the subject, and contain information about the research purpose, duration,
investigational procedures and alternatives to them, risks (possible adverse events, discomforts), benefits,
how confidentiality will be assured, how compensation for possible injuries will be provided, contact names
(at least one not associated with the study), a statement that participation is voluntary, and the subject can
withdraw at any time.

Good clinical practice (GCP) is an international quality standard for clinical trials involving human subjects.
The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical
principles for medical research involving human subjects.

Adverse event is any untoward medical occurrence associated with the use of a drug / device / procedure in
humans, whether considered drug / device / procedure related or not. Adverse reaction is any untoward
medical occurrence associated with the use of a drug / device / procedure in humans, considered drug /
device / procedure related.

Serious adverse event is an adverse event that leads to any of the following:

 death
 life-threatening situation
 hospitalization or prolongation of current hospitalization
 persistent or significant incapacity or substantial disruption of the ability to conduct normal life
functions
 congenital anomaly
 required Intervention to prevent permanent damage

Adverse events can be expected or unexpected based on previously published information about the
offender (drug / device / procedure).