RMM 042716

EOS 020316

THE ETHICAL RESEARCHER

COMPONENTS OF ETHICAL RESEARCH

1. For the good of the person

2. Scientific soundness
3. Ethical soundness
4. Researcher competence
5. Community involvement
 National Structural Framework for Human
Protection (Ethics) in Health Research 2006, 2014

FDA

Sponsor/ Sponsored Clinical Trials

REC Funding
Researcher Initiated
Agencies
Research
Participants

Investigator/ Research
PHREB Researcher Institutions
 AN ETHICAL RESEARCHER
• Qualified (by education and training)
• Humble and collegial
• Commands respect and is respectful himself
• Honest and trustworthy
• Competent and diligent
• Respects and follows rules and regulations
• Morally upright (has good sense of what is right
and what is not right)
THE IDEAL ETHICAL RESEARCHER
QUALIFIED
Submits proofs of qualification together with his
protocol such as:
• Signed and updated CV
• Updated evidence of training in research and
research ethics (GCP, Basic Ethics)
• References when required
HUMBLE and COLLEGIAL
• Seeks peer/authority opinions and assistance
when necessary
• Has good work ethics
• Respects the opinion of his co-investigators
• Admits mistakes he commits during conduct
of the research and offers or agrees to
suggested correction
• Apologizes for any harm done to participants
and seeks to alleviate it
COMMANDS RESPECT
AND IS RESPECTFUL HIMSELF
• Composes himself in a dignified and respectful
manner in his attire, actions, words
• Shows respect to research participants in his
manner of speaking and actions
• Keeps confidential matters about the research
confidential
HONEST, TRUSTWORTHY, and FAIR
• Explains objectives and procedures of protocol
to participants as well as to co-researchers
and staff truthfully
• Evokes trust by having thorough knowledge of
his research and procedures he is to do
• Assures participants of confidentiality and fair
treatment during recruitment and in the
administration of informed consent
DILIGENT and COMPETENT
• Provides a thorough background information
on his research that can be verified anytime
• Submits required documents or amendments
as soon as possible
• Respects deadlines
• Trains or make sure his staff is trained on
research ethics as well as in the conduct of his
protocol even before implementation
• Familiar with national and international ethics
guidelines
FOLLOWS RULES and REGULATIONS
• Gets institutional clearance for his research if
he is institution-affiliated
• Makes sure of completeness of documents
that need to be attached to his protocol
• Submits his protocol for technical and ethical
review and complies with requirements for
these
MORALLY UPRIGHT
• Can discern right from wrong
• Discloses any conflicts of interest
• Declares if protocol has been reviewed or
submitted for review by other RECs and
provides results of review
• Must not have been accused of fraud or other
immoral activities (in doing research) but if this
happens, he is ready to defend himself through
his track record, colleagues’ statements, etc.
MORALLY UPRIGHT
• Must not commit any SCIENTIFIC MISCONDUCT
before, during, after implementation of the
research.
 SCIENTIFIC MISCONDUCT
BEFORE STUDY IMPLEMENTATION

• Inaccurate/deceptive/manufactured
background information (CV, training,
credentials)
• Undocumented “references”
• Non-submission for ethical review and
approval
• Non-disclosure of conflict of interest
• “ghost writing, fabricating credentials,
and failure to disclose conflicts of
interest, rise to the level of scientific
misconduct...conflicts of interest can bias
the outcome of research. Thus, lack of
transparency to reviewers, journals and
readers for conflicts of interest should be
considered a form of scientific
misconduct”
Med Law (2007) 26:447-463 Medicine 447
Defining Scientific Misconduct
WHEN CONFLICT-OF-INTEREST IS A FACTOR IN SCIENTIFIC
MISCONDUCT Sheldon Krimsky*
 SCIENTIFIC MISCONDUCT
DURING STUDY IMPLEMENTATION
• Violation of ethical standards as in getting
informed consent, recruitment of participants,
etc.
• Intentional violation of approved protocol
procedures
• Violations of laws in gathering data
• Deception
• Non-disclosure of new information regarding
the investigational drug (if clinical trials)
 EXAMPLES OF ACTIONS THAT CONSTITUTE
MISTREATMENT OF RESEARCH PARTICIPANTS

• Absent or inadequate informed consent

• Maltreatment of laboratory animals
• Exposure of participants to physical or psychological
harm without informing them of the potential for
harm
• Exposure of participants (or the environment) to
harm because research practices or protocols do not
meet accepted and/or specified standards
• Failure to maintain confidentiality of human data
without specific consent from the participant
CONFIDENTIALITY:
Types of Identifiers
• Names • Account numbers
• Geographic information • Certificate/license
• Elements of dates numbers
(except year) (birth, • Vehicle identifiers (serial
death, admission, and numbers)
discharge dates) • Device identifiers
• Telephone numbers • URLs
• Fax numbers • IP address numbers
• E-mail addresses • Biometric identifiers
• Social security numbers • Full face photos
• Other unique identifier
 SCIENTIFIC MISCONDUCT DURING
DATA REPORTING/DATA STORAGE
• Fabrication
• Falsification
• Piracy
• Plagiarism
• Failure to keep data for future investigation
• Non-disclosure of negative data/data
suppression
• Misappropriation of data
• Photo manipulation
 SCIENTIFIC MISCONDUCT DURING
PUBLICATION OF STUDY RESULTS
• Multiple publication of same study data
(“salami” or multiple slicing), in a different
language/with a different title/different co-
investigators
• Ghostwriting
• Authorship (non-inclusion; exclusion; guest
authorship); refuses ”gift authorship”
• Provision of incorrect information to journals
• Undisclosed conflict of interests
 LESSONS FROM THE PAST
• It is very easy for people in power to take
advantage of those who are vulnerable and
are under their control.
• Prestigious institutions often get away with
unethical research because of their name and
money.
• Science can progress even at the expense of
man’s inhumanity to man.
 IN SUMMARY
BECAUSE:
• Human participants, environment, and
animals may be harmed, wronged or abused

RESEARCHERS MUST:
• Must develop ethical attitude towards work
• Realize the importance of ethics in doing
research
 IN SUMMARY
• The ethical researcher avoids /refuses to
commit any form of scientific misconduct even
under duress or promise of financial,
professional, or social gains
• “The virtuous professional can discern the
right course of action in the situation without
reliance on principles and rules, and/or that a
virtuous person will desire to do what is right,
apart from the threat of moral sanctions”.
THANK YOU! 