Ethical Considerations

[PLEASE MODIFY ACCORDINGLY]

The protocol of this study adheres to the ethical considerations and ethical principles set out
in relevant guidelines, including the Declaration of Helsinki, WHO guidelines, International
Conference on Harmonization-Good Clinical Practice, and National Ethics Guidelines for
Health Research.
IRB approval and informed consent
The study will only commence upon the approval of the Institutional Review Board. No
subject will participate in this study without written documentation of informed consent.
Data safety and confidentiality
Subject information will be kept in a secure office, with access available only to members of
the research team. Computerized study information will be stored on a secured network with
password access. All identifiable information and data will be given a code number. A
master list linking the code number and subject identity will be kept separately from the
research data. Only members of the research team will have access to the list. The research
records will be stored for at least [DAYS/MONTHS/YEARS] following completion of the
study. Individually identifiable research data will not be shared with others outside of the
research team.
The investigator and all key personnel will have completed the Good Clinical Practice (GCP)
training on the responsible conduct of research with human data. Monitoring of the study and
reporting of adverse events will be the responsibility of the primary investigator. In addition,
independent medical monitors [INCLUDE SPECIALTY OF MEDICAL MONITORS, IF
APPLICABLE] will hold separate monitoring for cross validation and safe conduction of the
study. Data monitoring will also include the proper attainment of informed consent and
adverse events. This information will be reviewed on an ongoing basis throughout the trial.
Compensation
[WHO WILL SHOULDER FINANCIAL EXPENSES, DECLARE SPONSORS OR
FUNDING AGENCIES, AND COMPENSATION OF SUBJECTS, IF APPLICABLE]
Adverse events
[WRITE ALL POSSIBLE RISKS AND DISCOMFORTS THAT COULD BE ENCOUNTERED BY
PARTICIPANTS]

In the event of a medical emergency, [INCLUDE EMERGENCY RESPONSE PLAN].

All serious adverse events will be reported to the IRB within ____ hours by telephone, fax or
e-mail. All other adverse events will be reported within ____ days. Any serious adverse
event associated with the protocol, however, will be cause for immediate termination of
participation by that subject.
Discontinuation
Any subject who previously consented may choose to withdraw from participation at any
point during the study. Any serious adverse event associated with the protocol will be cause
for immediate termination of participation by that subject.
Vulnerability
Vulnerable populations such as [INCLUDE VULNERABLE POPULATIONS AS
APPROPRIATE. FOR EXAMPLE: PREGNANT WOMEN, MINORS AND THOSE
UNABLE TO PROVIDE INFORMED CONSENT] are excluded.
Conflict of Interest
No potential conflicts of interest have been identified. The principal investigators and coinvestigators report no disclosures.